BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CTC VASOPRESS COMPRESSION SLEEVES

    MDR report key: 3060004 · Received April 11, 2013

    Report

    Report Number
    MW5029732
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    February 16, 2013
    Report Date
    April 4, 2013
    Manufacturer
    CTC COMPRESSION THERAPY CONCEPTS
    Product Code
    JOW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    (B)(6) SWITCHED VENDORS FOR PNEUMATIC COMPRESSION (DVT PROPHYLAXIS) IN (B)(6) 2012. WE SWITCHED FROM COVIDIEN/KENDALL TO A NEW VENDOR "COMPRESSION THERAPY CONCEPTS" OR "CTC". THE COMPRESSION SLEEVES ON THE KENDALL/COVIDIEN DEVICE ARE CIRCUMFERENTIAL AND SEQUENTIAL, WHILE THE CTC DEVICE CONSISTS OF A SINGLE POSTERIOR AIR BLADDER THAT IS INTENDED TO COMPRESS THE BACK OF THE CALF ONLY. A MAJOR FLAW IN THE CTC DEVICE IS THAT THEY EASILY ROTATE AROUND THE LEG WHEN THE PT MOVES, AND THE AIR BLADDER ENDS UP COMPRESSING ON THE SIDE OF THE LEG OR THE SHIN, MAKING THE DEVICE COMPLETELY INEFFECTIVE AND RESULTING IN SERIOUS PT CONSEQUENCES. OUTCOME: AFTER THE VENDOR CHANGE TO CTC, WE EXPERIENCED A SPIKE IN VTES, PARTICULARLY IN OUR HIGH RISK ICU, TRAUMATIC BRAIN INJURY, STROKE, AND SPINE SURGERY PTS WHO ARE DEPENDENT ON MECHANICAL PROPHYLAXIS. IN JUST 8 WEEKS ((B)(6)) DURING THE TIME WE USED THE CTC DEVICE, THERE WERE TEN (10) CASES OF VENOUS THROMBOEMBOLISM IN OUR SURGICAL ICU ALONE. SIX (6) OF THESE 10 CASES WERE BILATERAL LOWER EXTREMITY DVT. WE DEMANDED THAT THE CTC DEVICE BE REMOVED FROM OUR SICU (IT WAS REMOVED ON (B)(6)) AND BY (B)(6) THEY WERE REMOVED FROM THE REMAINDER OF NURSING UNITS. SINCE (B)(6), WE HAVE NOT HAD A SINGLE CASE OF DVT IN THE SICU (IT HAS BEEN 7 WEEKS), WITHOUT ANY OTHER CHANGE IN PT CARE OR NURSING PRACTICE. NOTE: THERE WERE ALSO CASES OF SKIN BREAKDOWN AND DEEP TISSUE INJURY ASSOCIATED WITH THE CTC DEVICE SLEEVES (SEE PHOTOS ATTACHED). THE LITERATURE CTC REFERENCES TO DEMONSTRATE THE EFFECTIVENESS OF THEIR PNEUMATIC COMPRESSION SYSTEM IS ACTUALLY FROM ANOTHER MFR (ANOTHER SINGLE-PULSE DEVICE CALLED "HUNTLIEGH"). THERE ARE NO CLINICAL OUTCOME STUDIES USING THE CTC DEVICE, AND ONLY ONE RANDOMIZED CONTROLLED TRIAL THAT WE CAN FIND IN THE PAST 15 YEARS STUDYING THE HUNTLIEGH DEVICE AND THIS SINGLE STUDY WAS PARTIALLY FUNDED BY THE MFR (GINZBURG, 2003). SURGICAL ICU PTS: (B)(6) - DVT LLE, DIAGNOSIS DATE: (B)(6) 2012 (USED CTC FOOT PUMPS). (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2012. (B)(6) - DVT RLE, DIAGNOSIS DATE: (B)(6) 2012. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE (B)(6) 2013. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT RLL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT RLL, DIAGNOSIS DATE: (B)(6) 2013. THERE HAS NOT BEEN SINGLE DVT IN OUR SURGICAL ICU SINCE CTC REMOVED FROM USE ON (B)(6) 2013. THE DOCUMENT THE CTC REP PROVIDED TO OUR MATERIALS MANAGEMENT DEPARTMENT TITLED "SEQUENTIAL COMPRESSION DEVICE CLINICAL STUDIES" IS INTENDED TO DEMONSTRATE THAT SEQUENTIAL COMPRESSION (MANUFACTURED BY KENDALL/COVIDIEN) IS ASSOCIATED WITH HIGH DVT RATES AND THAT THE CTC DEVICE IS SUPERIOR. THE STUDIES REFERENCED IN THIS PAPER ((B)(4)) ARE PERFORMED IN TOTAL JOINT REPLACEMENT (TJR) POPULATIONS, AND ARE UP TO 30 YEARS OLD, SOME CONDUCTED IN THE 1970'S, AND PUBLISHED IN 80'S AND 90'S. THIRTY YEARS AGO, TJR PT LENGTH OF STAY WAS MUCH LONGER THAN IT IS TODAY (UP TO 10 DAYS V. 2.5 DAYS), CHEMICAL PROPHYLAXIS WAS NOT COMMONPLACE, AND PTS WERE KEPT IMMOBILE FOR EXTENDED PERIODS OF TIME. THIS PLACED TJR PTS AT GREAT RISK FOR COMPLICATIONS, RESULTING IN VTE RATES UP TO (B)(4). THE "CLINICAL STUDIES" DOCUMENT THAT CTC PROMOTES AND PROVIDES TO HOSPITALS IN EFFORT TO CLINICALLY JUSTIFY THEIR PRODUCT IS A COMPLETE MISREPRESENTATION OF VTE RATES ASSOCIATED WITH SEQUENTIAL COMPRESSION. CTC WAS NOTIFIED ABOUT OUR INCREASED INCIDENCE OF DVT IN (B)(6) 2013, CTC RESPONDED BY ASKING US TO TRIAL THEIR "NEW" SEQUENTIAL "VASOGRAD" SLEEVES RATHER THAN SWITCHING VENDORS (BACK TO KENDALL/COVIDIEN). WHEN WE RECEIVED THE CTC SAMPLE VASOGRAD SLEEVES, WE TESTED THEM AND NOTED THAT THE SLEEVES DID NOT INFLATE ADEQUATELY. WE WENT ON TO FURTHER TEST THE SLEEVES BY CUTTING AWAY THE FABRIC AND OBSERVING THE ACTUAL ACTION OF THE INFLATION. WE CONFIRMED THAT THE AIR BLADDERS WITHIN THE SLEEVES DO NOT COMPLETELY INFLATE OR DO NOT INFLATE AT ALL ((B)(4)). EACH OF THE FOUR (4) VASOGRAD SAMPLES THAT CTC PROVIDED TO US FAILED. THE ADMINISTRATION OF (B)(6) WAS NOTIFIED REGARDING OUR HIGH INCIDENCE OF LOWER EXTREMITY DVT ASSOCIATED WITH THE NEW CTC DEVICE IN (B)(6) 2013. ADMINISTRATION ORDERED AN IMMEDIATE REMOVAL OF ALL CTC DEVICES WITHIN THE FACILITY WHICH WERE REPLACED WITH THE PRIOR VENDOR ((B)(4)). THE REPRESENTATIVES FOR CTC DENY ANY RESPONSIBILITY RELATED TO NEGATIVE PT OUTCOMES.

    Description of Event or Problem · 10

    (B)(6) SWITCHED VENDORS FOR PNEUMATIC COMPRESSION (DVT PROPHYLAXIS) IN (B)(6) 2012. WE SWITCHED FROM COVIDIEN/KENDALL TO A NEW VENDOR "COMPRESSION THERAPY CONCEPTS" OR "CTC". THE COMPRESSION SLEEVES ON THE KENDALL/COVIDIEN DEVICE ARE CIRCUMFERENTIAL AND SEQUENTIAL, WHILE THE CTC DEVICE CONSISTS OF A SINGLE POSTERIOR AIR BLADDER THAT IS INTENDED TO COMPRESS THE BACK OF THE CALF ONLY. A MAJOR FLAW IN THE CTC DEVICE IS THAT THEY EASILY ROTATE AROUND THE LEG WHEN THE PT MOVES, AND THE AIR BLADDER ENDS UP COMPRESSING ON THE SIDE OF THE LEG OR THE SHIN, MAKING THE DEVICE COMPLETELY INEFFECTIVE AND RESULTING IN SERIOUS PT CONSEQUENCES. OUTCOME: AFTER THE VENDOR CHANGE TO CTC, WE EXPERIENCED A SPIKE IN VTES, PARTICULARLY IN OUR HIGH RISK ICU, TRAUMATIC BRAIN INJURY, STROKE, AND SPINE SURGERY PTS WHO ARE DEPENDENT ON MECHANICAL PROPHYLAXIS. IN JUST 8 WEEKS ((B)(6)) DURING THE TIME WE USED THE CTC DEVICE, THERE WERE TEN (10) CASES OF VENOUS THROMBOEMBOLISM IN OUR SURGICAL ICU ALONE. SIX (6) OF THESE 10 CASES WERE BILATERAL LOWER EXTREMITY DVT. WE DEMANDED THAT THE CTC DEVICE BE REMOVED FROM OUR SICU (IT WAS REMOVED ON (B)(6)) AND BY (B)(6) THEY WERE REMOVED FROM THE REMAINDER OF NURSING UNITS. SINCE (B)(6), WE HAVE NOT HAD A SINGLE CASE OF DVT IN THE SICU (IT HAS BEEN 7 WEEKS), WITHOUT ANY OTHER CHANGE IN PT CARE OR NURSING PRACTICE. NOTE: THERE WERE ALSO CASES OF SKIN BREAKDOWN AND DEEP TISSUE INJURY ASSOCIATED WITH THE CTC DEVICE SLEEVES (SEE PHOTOS ATTACHED). THE LITERATURE CTC REFERENCES TO DEMONSTRATE THE EFFECTIVENESS OF THEIR PNEUMATIC COMPRESSION SYSTEM IS ACTUALLY FROM ANOTHER MFR (ANOTHER SINGLE-PULSE DEVICE CALLED "HUNTLIEGH"). THERE ARE NO CLINICAL OUTCOME STUDIES USING THE CTC DEVICE, AND ONLY ONE RANDOMIZED CONTROLLED TRIAL THAT WE CAN FIND IN THE PAST 15 YEARS STUDYING THE HUNTLIEGH DEVICE AND THIS SINGLE STUDY WAS PARTIALLY FUNDED BY THE MFR (GINZBURG, 2003). SURGICAL ICU PTS: (B)(6) - DVT LLE, DIAGNOSIS DATE: (B)(6) 2012 (USED CTC FOOT PUMPS). (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2012. (B)(6) - DVT RLE, DIAGNOSIS DATE: (B)(6) 2012. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE (B)(6) 2013. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT RLL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT RLL, DIAGNOSIS DATE: (B)(6) 2013. THERE HAS NOT BEEN SINGLE DVT IN OUR SURGICAL ICU SINCE CTC REMOVED FROM USE ON (B)(6) 2013. THE DOCUMENT THE CTC REP PROVIDED TO OUR MATERIALS MANAGEMENT DEPARTMENT TITLED "SEQUENTIAL COMPRESSION DEVICE CLINICAL STUDIES" IS INTENDED TO DEMONSTRATE THAT SEQUENTIAL COMPRESSION (MANUFACTURED BY KENDALL/COVIDIEN) IS ASSOCIATED WITH HIGH DVT RATES AND THAT THE CTC DEVICE IS SUPERIOR. THE STUDIES REFERENCED IN THIS PAPER ((B)(4)) ARE PERFORMED IN TOTAL JOINT REPLACEMENT (TJR) POPULATIONS, AND ARE UP TO 30 YEARS OLD, SOME CONDUCTED IN THE 1970'S, AND PUBLISHED IN 80'S AND 90'S. THIRTY YEARS AGO, TJR PT LENGTH OF STAY WAS MUCH LONGER THAN IT IS TODAY (UP TO 10 DAYS V. 2.5 DAYS), CHEMICAL PROPHYLAXIS WAS NOT COMMONPLACE, AND PTS WERE KEPT IMMOBILE FOR EXTENDED PERIODS OF TIME. THIS PLACED TJR PTS AT GREAT RISK FOR COMPLICATIONS, RESULTING IN VTE RATES UP TO (B)(4). THE "CLINICAL STUDIES" DOCUMENT THAT CTC PROMOTES AND PROVIDES TO HOSPITALS IN EFFORT TO CLINICALLY JUSTIFY THEIR PRODUCT IS A COMPLETE MISREPRESENTATION OF VTE RATES ASSOCIATED WITH SEQUENTIAL COMPRESSION. CTC WAS NOTIFIED ABOUT OUR INCREASED INCIDENCE OF DVT IN (B)(6) 2013, CTC RESPONDED BY ASKING US TO TRIAL THEIR "NEW" SEQUENTIAL "VASOGRAD" SLEEVES RATHER THAN SWITCHING VENDORS (BACK TO KENDALL/COVIDIEN). WHEN WE RECEIVED THE CTC SAMPLE VASOGRAD SLEEVES, WE TESTED THEM AND NOTED THAT THE SLEEVES DID NOT INFLATE ADEQUATELY. WE WENT ON TO FURTHER TEST THE SLEEVES BY CUTTING AWAY THE FABRIC AND OBSERVING THE ACTUAL ACTION OF THE INFLATION. WE CONFIRMED THAT THE AIR BLADDERS WITHIN THE SLEEVES DO NOT COMPLETELY INFLATE OR DO NOT INFLATE AT ALL ((B)(4)). EACH OF THE FOUR (4) VASOGRAD SAMPLES THAT CTC PROVIDED TO US FAILED. THE ADMINISTRATION OF (B)(6) WAS NOTIFIED REGARDING OUR HIGH INCIDENCE OF LOWER EXTREMITY DVT ASSOCIATED WITH THE NEW CTC DEVICE IN (B)(6) 2013. ADMINISTRATION ORDERED AN IMMEDIATE REMOVAL OF ALL CTC DEVICES WITHIN THE FACILITY WHICH WERE REPLACED WITH THE PRIOR VENDOR ((B)(4)). THE REPRESENTATIVES FOR CTC DENY ANY RESPONSIBILITY RELATED TO NEGATIVE PT OUTCOMES.

    Description of Event or Problem · 2

    (B)(6) SWITCHED VENDORS FOR PNEUMATIC COMPRESSION (DVT PROPHYLAXIS) IN (B)(6) 2012. WE SWITCHED FROM COVIDIEN/KENDALL TO A NEW VENDOR "COMPRESSION THERAPY CONCEPTS" OR "CTC". THE COMPRESSION SLEEVES ON THE KENDALL/COVIDIEN DEVICE ARE CIRCUMFERENTIAL AND SEQUENTIAL, WHILE THE CTC DEVICE CONSISTS OF A SINGLE POSTERIOR AIR BLADDER THAT IS INTENDED TO COMPRESS THE BACK OF THE CALF ONLY. A MAJOR FLAW IN THE CTC DEVICE IS THAT THEY EASILY ROTATE AROUND THE LEG WHEN THE PT MOVES, AND THE AIR BLADDER ENDS UP COMPRESSING ON THE SIDE OF THE LEG OR THE SHIN, MAKING THE DEVICE COMPLETELY INEFFECTIVE AND RESULTING IN SERIOUS PT CONSEQUENCES. OUTCOME: AFTER THE VENDOR CHANGE TO CTC, WE EXPERIENCED A SPIKE IN VTES, PARTICULARLY IN OUR HIGH RISK ICU, TRAUMATIC BRAIN INJURY, STROKE, AND SPINE SURGERY PTS WHO ARE DEPENDENT ON MECHANICAL PROPHYLAXIS. IN JUST 8 WEEKS ((B)(6)) DURING THE TIME WE USED THE CTC DEVICE, THERE WERE TEN (10) CASES OF VENOUS THROMBOEMBOLISM IN OUR SURGICAL ICU ALONE. SIX (6) OF THESE 10 CASES WERE BILATERAL LOWER EXTREMITY DVT. WE DEMANDED THAT THE CTC DEVICE BE REMOVED FROM OUR SICU (IT WAS REMOVED ON (B)(6)) AND BY (B)(6) THEY WERE REMOVED FROM THE REMAINDER OF NURSING UNITS. SINCE (B)(6), WE HAVE NOT HAD A SINGLE CASE OF DVT IN THE SICU (IT HAS BEEN 7 WEEKS), WITHOUT ANY OTHER CHANGE IN PT CARE OR NURSING PRACTICE. NOTE: THERE WERE ALSO CASES OF SKIN BREAKDOWN AND DEEP TISSUE INJURY ASSOCIATED WITH THE CTC DEVICE SLEEVES (SEE PHOTOS ATTACHED). THE LITERATURE CTC REFERENCES TO DEMONSTRATE THE EFFECTIVENESS OF THEIR PNEUMATIC COMPRESSION SYSTEM IS ACTUALLY FROM ANOTHER MFR (ANOTHER SINGLE-PULSE DEVICE CALLED "HUNTLIEGH"). THERE ARE NO CLINICAL OUTCOME STUDIES USING THE CTC DEVICE, AND ONLY ONE RANDOMIZED CONTROLLED TRIAL THAT WE CAN FIND IN THE PAST 15 YEARS STUDYING THE HUNTLIEGH DEVICE AND THIS SINGLE STUDY WAS PARTIALLY FUNDED BY THE MFR (GINZBURG, 2003). SURGICAL ICU PTS: (B)(6) - DVT LLE, DIAGNOSIS DATE: (B)(6) 2012 (USED CTC FOOT PUMPS). (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2012. (B)(6) - DVT RLE, DIAGNOSIS DATE: (B)(6) 2012. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE (B)(6) 2013. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT RLL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT RLL, DIAGNOSIS DATE: (B)(6) 2013. THERE HAS NOT BEEN SINGLE DVT IN OUR SURGICAL ICU SINCE CTC REMOVED FROM USE ON (B)(6) 2013. THE DOCUMENT THE CTC REP PROVIDED TO OUR MATERIALS MANAGEMENT DEPARTMENT TITLED "SEQUENTIAL COMPRESSION DEVICE CLINICAL STUDIES" IS INTENDED TO DEMONSTRATE THAT SEQUENTIAL COMPRESSION (MANUFACTURED BY KENDALL/COVIDIEN) IS ASSOCIATED WITH HIGH DVT RATES AND THAT THE CTC DEVICE IS SUPERIOR. THE STUDIES REFERENCED IN THIS PAPER ((B)(4)) ARE PERFORMED IN TOTAL JOINT REPLACEMENT (TJR) POPULATIONS, AND ARE UP TO 30 YEARS OLD, SOME CONDUCTED IN THE 1970'S, AND PUBLISHED IN 80'S AND 90'S. THIRTY YEARS AGO, TJR PT LENGTH OF STAY WAS MUCH LONGER THAN IT IS TODAY (UP TO 10 DAYS V. 2.5 DAYS), CHEMICAL PROPHYLAXIS WAS NOT COMMONPLACE, AND PTS WERE KEPT IMMOBILE FOR EXTENDED PERIODS OF TIME. THIS PLACED TJR PTS AT GREAT RISK FOR COMPLICATIONS, RESULTING IN VTE RATES UP TO (B)(4). THE "CLINICAL STUDIES" DOCUMENT THAT CTC PROMOTES AND PROVIDES TO HOSPITALS IN EFFORT TO CLINICALLY JUSTIFY THEIR PRODUCT IS A COMPLETE MISREPRESENTATION OF VTE RATES ASSOCIATED WITH SEQUENTIAL COMPRESSION. CTC WAS NOTIFIED ABOUT OUR INCREASED INCIDENCE OF DVT IN (B)(6) 2013, CTC RESPONDED BY ASKING US TO TRIAL THEIR "NEW" SEQUENTIAL "VASOGRAD" SLEEVES RATHER THAN SWITCHING VENDORS (BACK TO KENDALL/COVIDIEN). WHEN WE RECEIVED THE CTC SAMPLE VASOGRAD SLEEVES, WE TESTED THEM AND NOTED THAT THE SLEEVES DID NOT INFLATE ADEQUATELY. WE WENT ON TO FURTHER TEST THE SLEEVES BY CUTTING AWAY THE FABRIC AND OBSERVING THE ACTUAL ACTION OF THE INFLATION. WE CONFIRMED THAT THE AIR BLADDERS WITHIN THE SLEEVES DO NOT COMPLETELY INFLATE OR DO NOT INFLATE AT ALL ((B)(4)). EACH OF THE FOUR (4) VASOGRAD SAMPLES THAT CTC PROVIDED TO US FAILED. THE ADMINISTRATION OF (B)(6) WAS NOTIFIED REGARDING OUR HIGH INCIDENCE OF LOWER EXTREMITY DVT ASSOCIATED WITH THE NEW CTC DEVICE IN (B)(6) 2013. ADMINISTRATION ORDERED AN IMMEDIATE REMOVAL OF ALL CTC DEVICES WITHIN THE FACILITY WHICH WERE REPLACED WITH THE PRIOR VENDOR ((B)(4)). THE REPRESENTATIVES FOR CTC DENY ANY RESPONSIBILITY RELATED TO NEGATIVE PT OUTCOMES.

    Description of Event or Problem · 3

    (B)(6) SWITCHED VENDORS FOR PNEUMATIC COMPRESSION (DVT PROPHYLAXIS) IN (B)(6) 2012. WE SWITCHED FROM COVIDIEN/KENDALL TO A NEW VENDOR "COMPRESSION THERAPY CONCEPTS" OR "CTC". THE COMPRESSION SLEEVES ON THE KENDALL/COVIDIEN DEVICE ARE CIRCUMFERENTIAL AND SEQUENTIAL, WHILE THE CTC DEVICE CONSISTS OF A SINGLE POSTERIOR AIR BLADDER THAT IS INTENDED TO COMPRESS THE BACK OF THE CALF ONLY. A MAJOR FLAW IN THE CTC DEVICE IS THAT THEY EASILY ROTATE AROUND THE LEG WHEN THE PT MOVES, AND THE AIR BLADDER ENDS UP COMPRESSING ON THE SIDE OF THE LEG OR THE SHIN, MAKING THE DEVICE COMPLETELY INEFFECTIVE AND RESULTING IN SERIOUS PT CONSEQUENCES. OUTCOME: AFTER THE VENDOR CHANGE TO CTC, WE EXPERIENCED A SPIKE IN VTES, PARTICULARLY IN OUR HIGH RISK ICU, TRAUMATIC BRAIN INJURY, STROKE, AND SPINE SURGERY PTS WHO ARE DEPENDENT ON MECHANICAL PROPHYLAXIS. IN JUST 8 WEEKS ((B)(6)) DURING THE TIME WE USED THE CTC DEVICE, THERE WERE TEN (10) CASES OF VENOUS THROMBOEMBOLISM IN OUR SURGICAL ICU ALONE. SIX (6) OF THESE 10 CASES WERE BILATERAL LOWER EXTREMITY DVT. WE DEMANDED THAT THE CTC DEVICE BE REMOVED FROM OUR SICU (IT WAS REMOVED ON (B)(6)) AND BY (B)(6) THEY WERE REMOVED FROM THE REMAINDER OF NURSING UNITS. SINCE (B)(6), WE HAVE NOT HAD A SINGLE CASE OF DVT IN THE SICU (IT HAS BEEN 7 WEEKS), WITHOUT ANY OTHER CHANGE IN PT CARE OR NURSING PRACTICE. NOTE: THERE WERE ALSO CASES OF SKIN BREAKDOWN AND DEEP TISSUE INJURY ASSOCIATED WITH THE CTC DEVICE SLEEVES (SEE PHOTOS ATTACHED). THE LITERATURE CTC REFERENCES TO DEMONSTRATE THE EFFECTIVENESS OF THEIR PNEUMATIC COMPRESSION SYSTEM IS ACTUALLY FROM ANOTHER MFR (ANOTHER SINGLE-PULSE DEVICE CALLED "HUNTLIEGH"). THERE ARE NO CLINICAL OUTCOME STUDIES USING THE CTC DEVICE, AND ONLY ONE RANDOMIZED CONTROLLED TRIAL THAT WE CAN FIND IN THE PAST 15 YEARS STUDYING THE HUNTLIEGH DEVICE AND THIS SINGLE STUDY WAS PARTIALLY FUNDED BY THE MFR (GINZBURG, 2003). SURGICAL ICU PTS: (B)(6) - DVT LLE, DIAGNOSIS DATE: (B)(6) 2012 (USED CTC FOOT PUMPS). (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2012. (B)(6) - DVT RLE, DIAGNOSIS DATE: (B)(6) 2012. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE (B)(6) 2013. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT RLL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT RLL, DIAGNOSIS DATE: (B)(6) 2013. THERE HAS NOT BEEN SINGLE DVT IN OUR SURGICAL ICU SINCE CTC REMOVED FROM USE ON (B)(6) 2013. THE DOCUMENT THE CTC REP PROVIDED TO OUR MATERIALS MANAGEMENT DEPARTMENT TITLED "SEQUENTIAL COMPRESSION DEVICE CLINICAL STUDIES" IS INTENDED TO DEMONSTRATE THAT SEQUENTIAL COMPRESSION (MANUFACTURED BY KENDALL/COVIDIEN) IS ASSOCIATED WITH HIGH DVT RATES AND THAT THE CTC DEVICE IS SUPERIOR. THE STUDIES REFERENCED IN THIS PAPER ((B)(4)) ARE PERFORMED IN TOTAL JOINT REPLACEMENT (TJR) POPULATIONS, AND ARE UP TO 30 YEARS OLD, SOME CONDUCTED IN THE 1970'S, AND PUBLISHED IN 80'S AND 90'S. THIRTY YEARS AGO, TJR PT LENGTH OF STAY WAS MUCH LONGER THAN IT IS TODAY (UP TO 10 DAYS V. 2.5 DAYS), CHEMICAL PROPHYLAXIS WAS NOT COMMONPLACE, AND PTS WERE KEPT IMMOBILE FOR EXTENDED PERIODS OF TIME. THIS PLACED TJR PTS AT GREAT RISK FOR COMPLICATIONS, RESULTING IN VTE RATES UP TO (B)(4). THE "CLINICAL STUDIES" DOCUMENT THAT CTC PROMOTES AND PROVIDES TO HOSPITALS IN EFFORT TO CLINICALLY JUSTIFY THEIR PRODUCT IS A COMPLETE MISREPRESENTATION OF VTE RATES ASSOCIATED WITH SEQUENTIAL COMPRESSION. CTC WAS NOTIFIED ABOUT OUR INCREASED INCIDENCE OF DVT IN (B)(6) 2013, CTC RESPONDED BY ASKING US TO TRIAL THEIR "NEW" SEQUENTIAL "VASOGRAD" SLEEVES RATHER THAN SWITCHING VENDORS (BACK TO KENDALL/COVIDIEN). WHEN WE RECEIVED THE CTC SAMPLE VASOGRAD SLEEVES, WE TESTED THEM AND NOTED THAT THE SLEEVES DID NOT INFLATE ADEQUATELY. WE WENT ON TO FURTHER TEST THE SLEEVES BY CUTTING AWAY THE FABRIC AND OBSERVING THE ACTUAL ACTION OF THE INFLATION. WE CONFIRMED THAT THE AIR BLADDERS WITHIN THE SLEEVES DO NOT COMPLETELY INFLATE OR DO NOT INFLATE AT ALL ((B)(4)). EACH OF THE FOUR (4) VASOGRAD SAMPLES THAT CTC PROVIDED TO US FAILED. THE ADMINISTRATION OF (B)(6) WAS NOTIFIED REGARDING OUR HIGH INCIDENCE OF LOWER EXTREMITY DVT ASSOCIATED WITH THE NEW CTC DEVICE IN (B)(6) 2013. ADMINISTRATION ORDERED AN IMMEDIATE REMOVAL OF ALL CTC DEVICES WITHIN THE FACILITY WHICH WERE REPLACED WITH THE PRIOR VENDOR ((B)(4)). THE REPRESENTATIVES FOR CTC DENY ANY RESPONSIBILITY RELATED TO NEGATIVE PT OUTCOMES.

    Description of Event or Problem · 4

    (B)(6) SWITCHED VENDORS FOR PNEUMATIC COMPRESSION (DVT PROPHYLAXIS) IN (B)(6) 2012. WE SWITCHED FROM COVIDIEN/KENDALL TO A NEW VENDOR "COMPRESSION THERAPY CONCEPTS" OR "CTC". THE COMPRESSION SLEEVES ON THE KENDALL/COVIDIEN DEVICE ARE CIRCUMFERENTIAL AND SEQUENTIAL, WHILE THE CTC DEVICE CONSISTS OF A SINGLE POSTERIOR AIR BLADDER THAT IS INTENDED TO COMPRESS THE BACK OF THE CALF ONLY. A MAJOR FLAW IN THE CTC DEVICE IS THAT THEY EASILY ROTATE AROUND THE LEG WHEN THE PT MOVES, AND THE AIR BLADDER ENDS UP COMPRESSING ON THE SIDE OF THE LEG OR THE SHIN, MAKING THE DEVICE COMPLETELY INEFFECTIVE AND RESULTING IN SERIOUS PT CONSEQUENCES. OUTCOME: AFTER THE VENDOR CHANGE TO CTC, WE EXPERIENCED A SPIKE IN VTES, PARTICULARLY IN OUR HIGH RISK ICU, TRAUMATIC BRAIN INJURY, STROKE, AND SPINE SURGERY PTS WHO ARE DEPENDENT ON MECHANICAL PROPHYLAXIS. IN JUST 8 WEEKS ((B)(6)) DURING THE TIME WE USED THE CTC DEVICE, THERE WERE TEN (10) CASES OF VENOUS THROMBOEMBOLISM IN OUR SURGICAL ICU ALONE. SIX (6) OF THESE 10 CASES WERE BILATERAL LOWER EXTREMITY DVT. WE DEMANDED THAT THE CTC DEVICE BE REMOVED FROM OUR SICU (IT WAS REMOVED ON (B)(6)) AND BY (B)(6) THEY WERE REMOVED FROM THE REMAINDER OF NURSING UNITS. SINCE (B)(6), WE HAVE NOT HAD A SINGLE CASE OF DVT IN THE SICU (IT HAS BEEN 7 WEEKS), WITHOUT ANY OTHER CHANGE IN PT CARE OR NURSING PRACTICE. NOTE: THERE WERE ALSO CASES OF SKIN BREAKDOWN AND DEEP TISSUE INJURY ASSOCIATED WITH THE CTC DEVICE SLEEVES (SEE PHOTOS ATTACHED). THE LITERATURE CTC REFERENCES TO DEMONSTRATE THE EFFECTIVENESS OF THEIR PNEUMATIC COMPRESSION SYSTEM IS ACTUALLY FROM ANOTHER MFR (ANOTHER SINGLE-PULSE DEVICE CALLED "HUNTLIEGH"). THERE ARE NO CLINICAL OUTCOME STUDIES USING THE CTC DEVICE, AND ONLY ONE RANDOMIZED CONTROLLED TRIAL THAT WE CAN FIND IN THE PAST 15 YEARS STUDYING THE HUNTLIEGH DEVICE AND THIS SINGLE STUDY WAS PARTIALLY FUNDED BY THE MFR (GINZBURG, 2003). SURGICAL ICU PTS: (B)(6) - DVT LLE, DIAGNOSIS DATE: (B)(6) 2012 (USED CTC FOOT PUMPS). (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2012. (B)(6) - DVT RLE, DIAGNOSIS DATE: (B)(6) 2012. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE (B)(6) 2013. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT RLL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT RLL, DIAGNOSIS DATE: (B)(6) 2013. THERE HAS NOT BEEN SINGLE DVT IN OUR SURGICAL ICU SINCE CTC REMOVED FROM USE ON (B)(6) 2013. THE DOCUMENT THE CTC REP PROVIDED TO OUR MATERIALS MANAGEMENT DEPARTMENT TITLED "SEQUENTIAL COMPRESSION DEVICE CLINICAL STUDIES" IS INTENDED TO DEMONSTRATE THAT SEQUENTIAL COMPRESSION (MANUFACTURED BY KENDALL/COVIDIEN) IS ASSOCIATED WITH HIGH DVT RATES AND THAT THE CTC DEVICE IS SUPERIOR. THE STUDIES REFERENCED IN THIS PAPER ((B)(4)) ARE PERFORMED IN TOTAL JOINT REPLACEMENT (TJR) POPULATIONS, AND ARE UP TO 30 YEARS OLD, SOME CONDUCTED IN THE 1970'S, AND PUBLISHED IN 80'S AND 90'S. THIRTY YEARS AGO, TJR PT LENGTH OF STAY WAS MUCH LONGER THAN IT IS TODAY (UP TO 10 DAYS V. 2.5 DAYS), CHEMICAL PROPHYLAXIS WAS NOT COMMONPLACE, AND PTS WERE KEPT IMMOBILE FOR EXTENDED PERIODS OF TIME. THIS PLACED TJR PTS AT GREAT RISK FOR COMPLICATIONS, RESULTING IN VTE RATES UP TO (B)(4). THE "CLINICAL STUDIES" DOCUMENT THAT CTC PROMOTES AND PROVIDES TO HOSPITALS IN EFFORT TO CLINICALLY JUSTIFY THEIR PRODUCT IS A COMPLETE MISREPRESENTATION OF VTE RATES ASSOCIATED WITH SEQUENTIAL COMPRESSION. CTC WAS NOTIFIED ABOUT OUR INCREASED INCIDENCE OF DVT IN (B)(6) 2013, CTC RESPONDED BY ASKING US TO TRIAL THEIR "NEW" SEQUENTIAL "VASOGRAD" SLEEVES RATHER THAN SWITCHING VENDORS (BACK TO KENDALL/COVIDIEN). WHEN WE RECEIVED THE CTC SAMPLE VASOGRAD SLEEVES, WE TESTED THEM AND NOTED THAT THE SLEEVES DID NOT INFLATE ADEQUATELY. WE WENT ON TO FURTHER TEST THE SLEEVES BY CUTTING AWAY THE FABRIC AND OBSERVING THE ACTUAL ACTION OF THE INFLATION. WE CONFIRMED THAT THE AIR BLADDERS WITHIN THE SLEEVES DO NOT COMPLETELY INFLATE OR DO NOT INFLATE AT ALL ((B)(4)). EACH OF THE FOUR (4) VASOGRAD SAMPLES THAT CTC PROVIDED TO US FAILED. THE ADMINISTRATION OF (B)(6) WAS NOTIFIED REGARDING OUR HIGH INCIDENCE OF LOWER EXTREMITY DVT ASSOCIATED WITH THE NEW CTC DEVICE IN (B)(6) 2013. ADMINISTRATION ORDERED AN IMMEDIATE REMOVAL OF ALL CTC DEVICES WITHIN THE FACILITY WHICH WERE REPLACED WITH THE PRIOR VENDOR ((B)(4)). THE REPRESENTATIVES FOR CTC DENY ANY RESPONSIBILITY RELATED TO NEGATIVE PT OUTCOMES.

    Description of Event or Problem · 5

    (B)(6) SWITCHED VENDORS FOR PNEUMATIC COMPRESSION (DVT PROPHYLAXIS) IN (B)(6) 2012. WE SWITCHED FROM COVIDIEN/KENDALL TO A NEW VENDOR "COMPRESSION THERAPY CONCEPTS" OR "CTC". THE COMPRESSION SLEEVES ON THE KENDALL/COVIDIEN DEVICE ARE CIRCUMFERENTIAL AND SEQUENTIAL, WHILE THE CTC DEVICE CONSISTS OF A SINGLE POSTERIOR AIR BLADDER THAT IS INTENDED TO COMPRESS THE BACK OF THE CALF ONLY. A MAJOR FLAW IN THE CTC DEVICE IS THAT THEY EASILY ROTATE AROUND THE LEG WHEN THE PT MOVES, AND THE AIR BLADDER ENDS UP COMPRESSING ON THE SIDE OF THE LEG OR THE SHIN, MAKING THE DEVICE COMPLETELY INEFFECTIVE AND RESULTING IN SERIOUS PT CONSEQUENCES. OUTCOME: AFTER THE VENDOR CHANGE TO CTC, WE EXPERIENCED A SPIKE IN VTES, PARTICULARLY IN OUR HIGH RISK ICU, TRAUMATIC BRAIN INJURY, STROKE, AND SPINE SURGERY PTS WHO ARE DEPENDENT ON MECHANICAL PROPHYLAXIS. IN JUST 8 WEEKS ((B)(6)) DURING THE TIME WE USED THE CTC DEVICE, THERE WERE TEN (10) CASES OF VENOUS THROMBOEMBOLISM IN OUR SURGICAL ICU ALONE. SIX (6) OF THESE 10 CASES WERE BILATERAL LOWER EXTREMITY DVT. WE DEMANDED THAT THE CTC DEVICE BE REMOVED FROM OUR SICU (IT WAS REMOVED ON (B)(6)) AND BY (B)(6) THEY WERE REMOVED FROM THE REMAINDER OF NURSING UNITS. SINCE (B)(6), WE HAVE NOT HAD A SINGLE CASE OF DVT IN THE SICU (IT HAS BEEN 7 WEEKS), WITHOUT ANY OTHER CHANGE IN PT CARE OR NURSING PRACTICE. NOTE: THERE WERE ALSO CASES OF SKIN BREAKDOWN AND DEEP TISSUE INJURY ASSOCIATED WITH THE CTC DEVICE SLEEVES (SEE PHOTOS ATTACHED). THE LITERATURE CTC REFERENCES TO DEMONSTRATE THE EFFECTIVENESS OF THEIR PNEUMATIC COMPRESSION SYSTEM IS ACTUALLY FROM ANOTHER MFR (ANOTHER SINGLE-PULSE DEVICE CALLED "HUNTLIEGH"). THERE ARE NO CLINICAL OUTCOME STUDIES USING THE CTC DEVICE, AND ONLY ONE RANDOMIZED CONTROLLED TRIAL THAT WE CAN FIND IN THE PAST 15 YEARS STUDYING THE HUNTLIEGH DEVICE AND THIS SINGLE STUDY WAS PARTIALLY FUNDED BY THE MFR (GINZBURG, 2003). SURGICAL ICU PTS: (B)(6) - DVT LLE, DIAGNOSIS DATE: (B)(6) 2012 (USED CTC FOOT PUMPS). (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2012. (B)(6) - DVT RLE, DIAGNOSIS DATE: (B)(6) 2012. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE (B)(6) 2013. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT RLL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT RLL, DIAGNOSIS DATE: (B)(6) 2013. THERE HAS NOT BEEN SINGLE DVT IN OUR SURGICAL ICU SINCE CTC REMOVED FROM USE ON (B)(6) 2013. THE DOCUMENT THE CTC REP PROVIDED TO OUR MATERIALS MANAGEMENT DEPARTMENT TITLED "SEQUENTIAL COMPRESSION DEVICE CLINICAL STUDIES" IS INTENDED TO DEMONSTRATE THAT SEQUENTIAL COMPRESSION (MANUFACTURED BY KENDALL/COVIDIEN) IS ASSOCIATED WITH HIGH DVT RATES AND THAT THE CTC DEVICE IS SUPERIOR. THE STUDIES REFERENCED IN THIS PAPER ((B)(4)) ARE PERFORMED IN TOTAL JOINT REPLACEMENT (TJR) POPULATIONS, AND ARE UP TO 30 YEARS OLD, SOME CONDUCTED IN THE 1970'S, AND PUBLISHED IN 80'S AND 90'S. THIRTY YEARS AGO, TJR PT LENGTH OF STAY WAS MUCH LONGER THAN IT IS TODAY (UP TO 10 DAYS V. 2.5 DAYS), CHEMICAL PROPHYLAXIS WAS NOT COMMONPLACE, AND PTS WERE KEPT IMMOBILE FOR EXTENDED PERIODS OF TIME. THIS PLACED TJR PTS AT GREAT RISK FOR COMPLICATIONS, RESULTING IN VTE RATES UP TO (B)(4). THE "CLINICAL STUDIES" DOCUMENT THAT CTC PROMOTES AND PROVIDES TO HOSPITALS IN EFFORT TO CLINICALLY JUSTIFY THEIR PRODUCT IS A COMPLETE MISREPRESENTATION OF VTE RATES ASSOCIATED WITH SEQUENTIAL COMPRESSION. CTC WAS NOTIFIED ABOUT OUR INCREASED INCIDENCE OF DVT IN (B)(6) 2013, CTC RESPONDED BY ASKING US TO TRIAL THEIR "NEW" SEQUENTIAL "VASOGRAD" SLEEVES RATHER THAN SWITCHING VENDORS (BACK TO KENDALL/COVIDIEN). WHEN WE RECEIVED THE CTC SAMPLE VASOGRAD SLEEVES, WE TESTED THEM AND NOTED THAT THE SLEEVES DID NOT INFLATE ADEQUATELY. WE WENT ON TO FURTHER TEST THE SLEEVES BY CUTTING AWAY THE FABRIC AND OBSERVING THE ACTUAL ACTION OF THE INFLATION. WE CONFIRMED THAT THE AIR BLADDERS WITHIN THE SLEEVES DO NOT COMPLETELY INFLATE OR DO NOT INFLATE AT ALL ((B)(4)). EACH OF THE FOUR (4) VASOGRAD SAMPLES THAT CTC PROVIDED TO US FAILED. THE ADMINISTRATION OF (B)(6) WAS NOTIFIED REGARDING OUR HIGH INCIDENCE OF LOWER EXTREMITY DVT ASSOCIATED WITH THE NEW CTC DEVICE IN (B)(6) 2013. ADMINISTRATION ORDERED AN IMMEDIATE REMOVAL OF ALL CTC DEVICES WITHIN THE FACILITY WHICH WERE REPLACED WITH THE PRIOR VENDOR ((B)(4)). THE REPRESENTATIVES FOR CTC DENY ANY RESPONSIBILITY RELATED TO NEGATIVE PT OUTCOMES.

    Description of Event or Problem · 6

    (B)(6) SWITCHED VENDORS FOR PNEUMATIC COMPRESSION (DVT PROPHYLAXIS) IN (B)(6) 2012. WE SWITCHED FROM COVIDIEN/KENDALL TO A NEW VENDOR "COMPRESSION THERAPY CONCEPTS" OR "CTC". THE COMPRESSION SLEEVES ON THE KENDALL/COVIDIEN DEVICE ARE CIRCUMFERENTIAL AND SEQUENTIAL, WHILE THE CTC DEVICE CONSISTS OF A SINGLE POSTERIOR AIR BLADDER THAT IS INTENDED TO COMPRESS THE BACK OF THE CALF ONLY. A MAJOR FLAW IN THE CTC DEVICE IS THAT THEY EASILY ROTATE AROUND THE LEG WHEN THE PT MOVES, AND THE AIR BLADDER ENDS UP COMPRESSING ON THE SIDE OF THE LEG OR THE SHIN, MAKING THE DEVICE COMPLETELY INEFFECTIVE AND RESULTING IN SERIOUS PT CONSEQUENCES. OUTCOME: AFTER THE VENDOR CHANGE TO CTC, WE EXPERIENCED A SPIKE IN VTES, PARTICULARLY IN OUR HIGH RISK ICU, TRAUMATIC BRAIN INJURY, STROKE, AND SPINE SURGERY PTS WHO ARE DEPENDENT ON MECHANICAL PROPHYLAXIS. IN JUST 8 WEEKS ((B)(6)) DURING THE TIME WE USED THE CTC DEVICE, THERE WERE TEN (10) CASES OF VENOUS THROMBOEMBOLISM IN OUR SURGICAL ICU ALONE. SIX (6) OF THESE 10 CASES WERE BILATERAL LOWER EXTREMITY DVT. WE DEMANDED THAT THE CTC DEVICE BE REMOVED FROM OUR SICU (IT WAS REMOVED ON (B)(6)) AND BY (B)(6) THEY WERE REMOVED FROM THE REMAINDER OF NURSING UNITS. SINCE (B)(6), WE HAVE NOT HAD A SINGLE CASE OF DVT IN THE SICU (IT HAS BEEN 7 WEEKS), WITHOUT ANY OTHER CHANGE IN PT CARE OR NURSING PRACTICE. NOTE: THERE WERE ALSO CASES OF SKIN BREAKDOWN AND DEEP TISSUE INJURY ASSOCIATED WITH THE CTC DEVICE SLEEVES (SEE PHOTOS ATTACHED). THE LITERATURE CTC REFERENCES TO DEMONSTRATE THE EFFECTIVENESS OF THEIR PNEUMATIC COMPRESSION SYSTEM IS ACTUALLY FROM ANOTHER MFR (ANOTHER SINGLE-PULSE DEVICE CALLED "HUNTLIEGH"). THERE ARE NO CLINICAL OUTCOME STUDIES USING THE CTC DEVICE, AND ONLY ONE RANDOMIZED CONTROLLED TRIAL THAT WE CAN FIND IN THE PAST 15 YEARS STUDYING THE HUNTLIEGH DEVICE AND THIS SINGLE STUDY WAS PARTIALLY FUNDED BY THE MFR (GINZBURG, 2003). SURGICAL ICU PTS: (B)(6) - DVT LLE, DIAGNOSIS DATE: (B)(6) 2012 (USED CTC FOOT PUMPS). (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2012. (B)(6) - DVT RLE, DIAGNOSIS DATE: (B)(6) 2012. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE (B)(6) 2013. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT RLL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT RLL, DIAGNOSIS DATE: (B)(6) 2013. THERE HAS NOT BEEN SINGLE DVT IN OUR SURGICAL ICU SINCE CTC REMOVED FROM USE ON (B)(6) 2013. THE DOCUMENT THE CTC REP PROVIDED TO OUR MATERIALS MANAGEMENT DEPARTMENT TITLED "SEQUENTIAL COMPRESSION DEVICE CLINICAL STUDIES" IS INTENDED TO DEMONSTRATE THAT SEQUENTIAL COMPRESSION (MANUFACTURED BY KENDALL/COVIDIEN) IS ASSOCIATED WITH HIGH DVT RATES AND THAT THE CTC DEVICE IS SUPERIOR. THE STUDIES REFERENCED IN THIS PAPER ((B)(4)) ARE PERFORMED IN TOTAL JOINT REPLACEMENT (TJR) POPULATIONS, AND ARE UP TO 30 YEARS OLD, SOME CONDUCTED IN THE 1970'S, AND PUBLISHED IN 80'S AND 90'S. THIRTY YEARS AGO, TJR PT LENGTH OF STAY WAS MUCH LONGER THAN IT IS TODAY (UP TO 10 DAYS V. 2.5 DAYS), CHEMICAL PROPHYLAXIS WAS NOT COMMONPLACE, AND PTS WERE KEPT IMMOBILE FOR EXTENDED PERIODS OF TIME. THIS PLACED TJR PTS AT GREAT RISK FOR COMPLICATIONS, RESULTING IN VTE RATES UP TO (B)(4). THE "CLINICAL STUDIES" DOCUMENT THAT CTC PROMOTES AND PROVIDES TO HOSPITALS IN EFFORT TO CLINICALLY JUSTIFY THEIR PRODUCT IS A COMPLETE MISREPRESENTATION OF VTE RATES ASSOCIATED WITH SEQUENTIAL COMPRESSION. CTC WAS NOTIFIED ABOUT OUR INCREASED INCIDENCE OF DVT IN (B)(6) 2013, CTC RESPONDED BY ASKING US TO TRIAL THEIR "NEW" SEQUENTIAL "VASOGRAD" SLEEVES RATHER THAN SWITCHING VENDORS (BACK TO KENDALL/COVIDIEN). WHEN WE RECEIVED THE CTC SAMPLE VASOGRAD SLEEVES, WE TESTED THEM AND NOTED THAT THE SLEEVES DID NOT INFLATE ADEQUATELY. WE WENT ON TO FURTHER TEST THE SLEEVES BY CUTTING AWAY THE FABRIC AND OBSERVING THE ACTUAL ACTION OF THE INFLATION. WE CONFIRMED THAT THE AIR BLADDERS WITHIN THE SLEEVES DO NOT COMPLETELY INFLATE OR DO NOT INFLATE AT ALL ((B)(4)). EACH OF THE FOUR (4) VASOGRAD SAMPLES THAT CTC PROVIDED TO US FAILED. THE ADMINISTRATION OF (B)(6) WAS NOTIFIED REGARDING OUR HIGH INCIDENCE OF LOWER EXTREMITY DVT ASSOCIATED WITH THE NEW CTC DEVICE IN (B)(6) 2013. ADMINISTRATION ORDERED AN IMMEDIATE REMOVAL OF ALL CTC DEVICES WITHIN THE FACILITY WHICH WERE REPLACED WITH THE PRIOR VENDOR ((B)(4)). THE REPRESENTATIVES FOR CTC DENY ANY RESPONSIBILITY RELATED TO NEGATIVE PT OUTCOMES.

    Description of Event or Problem · 7

    (B)(6) SWITCHED VENDORS FOR PNEUMATIC COMPRESSION (DVT PROPHYLAXIS) IN (B)(6) 2012. WE SWITCHED FROM COVIDIEN/KENDALL TO A NEW VENDOR "COMPRESSION THERAPY CONCEPTS" OR "CTC". THE COMPRESSION SLEEVES ON THE KENDALL/COVIDIEN DEVICE ARE CIRCUMFERENTIAL AND SEQUENTIAL, WHILE THE CTC DEVICE CONSISTS OF A SINGLE POSTERIOR AIR BLADDER THAT IS INTENDED TO COMPRESS THE BACK OF THE CALF ONLY. A MAJOR FLAW IN THE CTC DEVICE IS THAT THEY EASILY ROTATE AROUND THE LEG WHEN THE PT MOVES, AND THE AIR BLADDER ENDS UP COMPRESSING ON THE SIDE OF THE LEG OR THE SHIN, MAKING THE DEVICE COMPLETELY INEFFECTIVE AND RESULTING IN SERIOUS PT CONSEQUENCES. OUTCOME: AFTER THE VENDOR CHANGE TO CTC, WE EXPERIENCED A SPIKE IN VTES, PARTICULARLY IN OUR HIGH RISK ICU, TRAUMATIC BRAIN INJURY, STROKE, AND SPINE SURGERY PTS WHO ARE DEPENDENT ON MECHANICAL PROPHYLAXIS. IN JUST 8 WEEKS ((B)(6)) DURING THE TIME WE USED THE CTC DEVICE, THERE WERE TEN (10) CASES OF VENOUS THROMBOEMBOLISM IN OUR SURGICAL ICU ALONE. SIX (6) OF THESE 10 CASES WERE BILATERAL LOWER EXTREMITY DVT. WE DEMANDED THAT THE CTC DEVICE BE REMOVED FROM OUR SICU (IT WAS REMOVED ON (B)(6)) AND BY (B)(6) THEY WERE REMOVED FROM THE REMAINDER OF NURSING UNITS. SINCE (B)(6), WE HAVE NOT HAD A SINGLE CASE OF DVT IN THE SICU (IT HAS BEEN 7 WEEKS), WITHOUT ANY OTHER CHANGE IN PT CARE OR NURSING PRACTICE. NOTE: THERE WERE ALSO CASES OF SKIN BREAKDOWN AND DEEP TISSUE INJURY ASSOCIATED WITH THE CTC DEVICE SLEEVES (SEE PHOTOS ATTACHED). THE LITERATURE CTC REFERENCES TO DEMONSTRATE THE EFFECTIVENESS OF THEIR PNEUMATIC COMPRESSION SYSTEM IS ACTUALLY FROM ANOTHER MFR (ANOTHER SINGLE-PULSE DEVICE CALLED "HUNTLIEGH"). THERE ARE NO CLINICAL OUTCOME STUDIES USING THE CTC DEVICE, AND ONLY ONE RANDOMIZED CONTROLLED TRIAL THAT WE CAN FIND IN THE PAST 15 YEARS STUDYING THE HUNTLIEGH DEVICE AND THIS SINGLE STUDY WAS PARTIALLY FUNDED BY THE MFR (GINZBURG, 2003). SURGICAL ICU PTS: (B)(6) - DVT LLE, DIAGNOSIS DATE: (B)(6) 2012 (USED CTC FOOT PUMPS). (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2012. (B)(6) - DVT RLE, DIAGNOSIS DATE: (B)(6) 2012. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE (B)(6) 2013. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT RLL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT RLL, DIAGNOSIS DATE: (B)(6) 2013. THERE HAS NOT BEEN SINGLE DVT IN OUR SURGICAL ICU SINCE CTC REMOVED FROM USE ON (B)(6) 2013. THE DOCUMENT THE CTC REP PROVIDED TO OUR MATERIALS MANAGEMENT DEPARTMENT TITLED "SEQUENTIAL COMPRESSION DEVICE CLINICAL STUDIES" IS INTENDED TO DEMONSTRATE THAT SEQUENTIAL COMPRESSION (MANUFACTURED BY KENDALL/COVIDIEN) IS ASSOCIATED WITH HIGH DVT RATES AND THAT THE CTC DEVICE IS SUPERIOR. THE STUDIES REFERENCED IN THIS PAPER ((B)(4)) ARE PERFORMED IN TOTAL JOINT REPLACEMENT (TJR) POPULATIONS, AND ARE UP TO 30 YEARS OLD, SOME CONDUCTED IN THE 1970'S, AND PUBLISHED IN 80'S AND 90'S. THIRTY YEARS AGO, TJR PT LENGTH OF STAY WAS MUCH LONGER THAN IT IS TODAY (UP TO 10 DAYS V. 2.5 DAYS), CHEMICAL PROPHYLAXIS WAS NOT COMMONPLACE, AND PTS WERE KEPT IMMOBILE FOR EXTENDED PERIODS OF TIME. THIS PLACED TJR PTS AT GREAT RISK FOR COMPLICATIONS, RESULTING IN VTE RATES UP TO (B)(4). THE "CLINICAL STUDIES" DOCUMENT THAT CTC PROMOTES AND PROVIDES TO HOSPITALS IN EFFORT TO CLINICALLY JUSTIFY THEIR PRODUCT IS A COMPLETE MISREPRESENTATION OF VTE RATES ASSOCIATED WITH SEQUENTIAL COMPRESSION. CTC WAS NOTIFIED ABOUT OUR INCREASED INCIDENCE OF DVT IN (B)(6) 2013, CTC RESPONDED BY ASKING US TO TRIAL THEIR "NEW" SEQUENTIAL "VASOGRAD" SLEEVES RATHER THAN SWITCHING VENDORS (BACK TO KENDALL/COVIDIEN). WHEN WE RECEIVED THE CTC SAMPLE VASOGRAD SLEEVES, WE TESTED THEM AND NOTED THAT THE SLEEVES DID NOT INFLATE ADEQUATELY. WE WENT ON TO FURTHER TEST THE SLEEVES BY CUTTING AWAY THE FABRIC AND OBSERVING THE ACTUAL ACTION OF THE INFLATION. WE CONFIRMED THAT THE AIR BLADDERS WITHIN THE SLEEVES DO NOT COMPLETELY INFLATE OR DO NOT INFLATE AT ALL ((B)(4)). EACH OF THE FOUR (4) VASOGRAD SAMPLES THAT CTC PROVIDED TO US FAILED. THE ADMINISTRATION OF (B)(6) WAS NOTIFIED REGARDING OUR HIGH INCIDENCE OF LOWER EXTREMITY DVT ASSOCIATED WITH THE NEW CTC DEVICE IN (B)(6) 2013. ADMINISTRATION ORDERED AN IMMEDIATE REMOVAL OF ALL CTC DEVICES WITHIN THE FACILITY WHICH WERE REPLACED WITH THE PRIOR VENDOR ((B)(4)). THE REPRESENTATIVES FOR CTC DENY ANY RESPONSIBILITY RELATED TO NEGATIVE PT OUTCOMES.

    Description of Event or Problem · 8

    (B)(6) SWITCHED VENDORS FOR PNEUMATIC COMPRESSION (DVT PROPHYLAXIS) IN (B)(6) 2012. WE SWITCHED FROM COVIDIEN/KENDALL TO A NEW VENDOR "COMPRESSION THERAPY CONCEPTS" OR "CTC". THE COMPRESSION SLEEVES ON THE KENDALL/COVIDIEN DEVICE ARE CIRCUMFERENTIAL AND SEQUENTIAL, WHILE THE CTC DEVICE CONSISTS OF A SINGLE POSTERIOR AIR BLADDER THAT IS INTENDED TO COMPRESS THE BACK OF THE CALF ONLY. A MAJOR FLAW IN THE CTC DEVICE IS THAT THEY EASILY ROTATE AROUND THE LEG WHEN THE PT MOVES, AND THE AIR BLADDER ENDS UP COMPRESSING ON THE SIDE OF THE LEG OR THE SHIN, MAKING THE DEVICE COMPLETELY INEFFECTIVE AND RESULTING IN SERIOUS PT CONSEQUENCES. OUTCOME: AFTER THE VENDOR CHANGE TO CTC, WE EXPERIENCED A SPIKE IN VTES, PARTICULARLY IN OUR HIGH RISK ICU, TRAUMATIC BRAIN INJURY, STROKE, AND SPINE SURGERY PTS WHO ARE DEPENDENT ON MECHANICAL PROPHYLAXIS. IN JUST 8 WEEKS ((B)(6)) DURING THE TIME WE USED THE CTC DEVICE, THERE WERE TEN (10) CASES OF VENOUS THROMBOEMBOLISM IN OUR SURGICAL ICU ALONE. SIX (6) OF THESE 10 CASES WERE BILATERAL LOWER EXTREMITY DVT. WE DEMANDED THAT THE CTC DEVICE BE REMOVED FROM OUR SICU (IT WAS REMOVED ON (B)(6)) AND BY (B)(6) THEY WERE REMOVED FROM THE REMAINDER OF NURSING UNITS. SINCE (B)(6), WE HAVE NOT HAD A SINGLE CASE OF DVT IN THE SICU (IT HAS BEEN 7 WEEKS), WITHOUT ANY OTHER CHANGE IN PT CARE OR NURSING PRACTICE. NOTE: THERE WERE ALSO CASES OF SKIN BREAKDOWN AND DEEP TISSUE INJURY ASSOCIATED WITH THE CTC DEVICE SLEEVES (SEE PHOTOS ATTACHED). THE LITERATURE CTC REFERENCES TO DEMONSTRATE THE EFFECTIVENESS OF THEIR PNEUMATIC COMPRESSION SYSTEM IS ACTUALLY FROM ANOTHER MFR (ANOTHER SINGLE-PULSE DEVICE CALLED "HUNTLIEGH"). THERE ARE NO CLINICAL OUTCOME STUDIES USING THE CTC DEVICE, AND ONLY ONE RANDOMIZED CONTROLLED TRIAL THAT WE CAN FIND IN THE PAST 15 YEARS STUDYING THE HUNTLIEGH DEVICE AND THIS SINGLE STUDY WAS PARTIALLY FUNDED BY THE MFR (GINZBURG, 2003). SURGICAL ICU PTS: (B)(6) - DVT LLE, DIAGNOSIS DATE: (B)(6) 2012 (USED CTC FOOT PUMPS). (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2012. (B)(6) - DVT RLE, DIAGNOSIS DATE: (B)(6) 2012. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE (B)(6) 2013. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT RLL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT RLL, DIAGNOSIS DATE: (B)(6) 2013. THERE HAS NOT BEEN SINGLE DVT IN OUR SURGICAL ICU SINCE CTC REMOVED FROM USE ON (B)(6) 2013. THE DOCUMENT THE CTC REP PROVIDED TO OUR MATERIALS MANAGEMENT DEPARTMENT TITLED "SEQUENTIAL COMPRESSION DEVICE CLINICAL STUDIES" IS INTENDED TO DEMONSTRATE THAT SEQUENTIAL COMPRESSION (MANUFACTURED BY KENDALL/COVIDIEN) IS ASSOCIATED WITH HIGH DVT RATES AND THAT THE CTC DEVICE IS SUPERIOR. THE STUDIES REFERENCED IN THIS PAPER ((B)(4)) ARE PERFORMED IN TOTAL JOINT REPLACEMENT (TJR) POPULATIONS, AND ARE UP TO 30 YEARS OLD, SOME CONDUCTED IN THE 1970'S, AND PUBLISHED IN 80'S AND 90'S. THIRTY YEARS AGO, TJR PT LENGTH OF STAY WAS MUCH LONGER THAN IT IS TODAY (UP TO 10 DAYS V. 2.5 DAYS), CHEMICAL PROPHYLAXIS WAS NOT COMMONPLACE, AND PTS WERE KEPT IMMOBILE FOR EXTENDED PERIODS OF TIME. THIS PLACED TJR PTS AT GREAT RISK FOR COMPLICATIONS, RESULTING IN VTE RATES UP TO (B)(4). THE "CLINICAL STUDIES" DOCUMENT THAT CTC PROMOTES AND PROVIDES TO HOSPITALS IN EFFORT TO CLINICALLY JUSTIFY THEIR PRODUCT IS A COMPLETE MISREPRESENTATION OF VTE RATES ASSOCIATED WITH SEQUENTIAL COMPRESSION. CTC WAS NOTIFIED ABOUT OUR INCREASED INCIDENCE OF DVT IN (B)(6) 2013, CTC RESPONDED BY ASKING US TO TRIAL THEIR "NEW" SEQUENTIAL "VASOGRAD" SLEEVES RATHER THAN SWITCHING VENDORS (BACK TO KENDALL/COVIDIEN). WHEN WE RECEIVED THE CTC SAMPLE VASOGRAD SLEEVES, WE TESTED THEM AND NOTED THAT THE SLEEVES DID NOT INFLATE ADEQUATELY. WE WENT ON TO FURTHER TEST THE SLEEVES BY CUTTING AWAY THE FABRIC AND OBSERVING THE ACTUAL ACTION OF THE INFLATION. WE CONFIRMED THAT THE AIR BLADDERS WITHIN THE SLEEVES DO NOT COMPLETELY INFLATE OR DO NOT INFLATE AT ALL ((B)(4)). EACH OF THE FOUR (4) VASOGRAD SAMPLES THAT CTC PROVIDED TO US FAILED. THE ADMINISTRATION OF (B)(6) WAS NOTIFIED REGARDING OUR HIGH INCIDENCE OF LOWER EXTREMITY DVT ASSOCIATED WITH THE NEW CTC DEVICE IN (B)(6) 2013. ADMINISTRATION ORDERED AN IMMEDIATE REMOVAL OF ALL CTC DEVICES WITHIN THE FACILITY WHICH WERE REPLACED WITH THE PRIOR VENDOR ((B)(4)). THE REPRESENTATIVES FOR CTC DENY ANY RESPONSIBILITY RELATED TO NEGATIVE PT OUTCOMES.

    Description of Event or Problem · 9

    (B)(6) SWITCHED VENDORS FOR PNEUMATIC COMPRESSION (DVT PROPHYLAXIS) IN (B)(6) 2012. WE SWITCHED FROM COVIDIEN/KENDALL TO A NEW VENDOR "COMPRESSION THERAPY CONCEPTS" OR "CTC". THE COMPRESSION SLEEVES ON THE KENDALL/COVIDIEN DEVICE ARE CIRCUMFERENTIAL AND SEQUENTIAL, WHILE THE CTC DEVICE CONSISTS OF A SINGLE POSTERIOR AIR BLADDER THAT IS INTENDED TO COMPRESS THE BACK OF THE CALF ONLY. A MAJOR FLAW IN THE CTC DEVICE IS THAT THEY EASILY ROTATE AROUND THE LEG WHEN THE PT MOVES, AND THE AIR BLADDER ENDS UP COMPRESSING ON THE SIDE OF THE LEG OR THE SHIN, MAKING THE DEVICE COMPLETELY INEFFECTIVE AND RESULTING IN SERIOUS PT CONSEQUENCES. OUTCOME: AFTER THE VENDOR CHANGE TO CTC, WE EXPERIENCED A SPIKE IN VTES, PARTICULARLY IN OUR HIGH RISK ICU, TRAUMATIC BRAIN INJURY, STROKE, AND SPINE SURGERY PTS WHO ARE DEPENDENT ON MECHANICAL PROPHYLAXIS. IN JUST 8 WEEKS ((B)(6)) DURING THE TIME WE USED THE CTC DEVICE, THERE WERE TEN (10) CASES OF VENOUS THROMBOEMBOLISM IN OUR SURGICAL ICU ALONE. SIX (6) OF THESE 10 CASES WERE BILATERAL LOWER EXTREMITY DVT. WE DEMANDED THAT THE CTC DEVICE BE REMOVED FROM OUR SICU (IT WAS REMOVED ON (B)(6)) AND BY (B)(6) THEY WERE REMOVED FROM THE REMAINDER OF NURSING UNITS. SINCE (B)(6), WE HAVE NOT HAD A SINGLE CASE OF DVT IN THE SICU (IT HAS BEEN 7 WEEKS), WITHOUT ANY OTHER CHANGE IN PT CARE OR NURSING PRACTICE. NOTE: THERE WERE ALSO CASES OF SKIN BREAKDOWN AND DEEP TISSUE INJURY ASSOCIATED WITH THE CTC DEVICE SLEEVES (SEE PHOTOS ATTACHED). THE LITERATURE CTC REFERENCES TO DEMONSTRATE THE EFFECTIVENESS OF THEIR PNEUMATIC COMPRESSION SYSTEM IS ACTUALLY FROM ANOTHER MFR (ANOTHER SINGLE-PULSE DEVICE CALLED "HUNTLIEGH"). THERE ARE NO CLINICAL OUTCOME STUDIES USING THE CTC DEVICE, AND ONLY ONE RANDOMIZED CONTROLLED TRIAL THAT WE CAN FIND IN THE PAST 15 YEARS STUDYING THE HUNTLIEGH DEVICE AND THIS SINGLE STUDY WAS PARTIALLY FUNDED BY THE MFR (GINZBURG, 2003). SURGICAL ICU PTS: (B)(6) - DVT LLE, DIAGNOSIS DATE: (B)(6) 2012 (USED CTC FOOT PUMPS). (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2012. (B)(6) - DVT RLE, DIAGNOSIS DATE: (B)(6) 2012. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE (B)(6) 2013. (B)(6) - DVT BILATERAL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT RLL, DIAGNOSIS DATE: (B)(6) 2013. (B)(6) - DVT RLL, DIAGNOSIS DATE: (B)(6) 2013. THERE HAS NOT BEEN SINGLE DVT IN OUR SURGICAL ICU SINCE CTC REMOVED FROM USE ON (B)(6) 2013. THE DOCUMENT THE CTC REP PROVIDED TO OUR MATERIALS MANAGEMENT DEPARTMENT TITLED "SEQUENTIAL COMPRESSION DEVICE CLINICAL STUDIES" IS INTENDED TO DEMONSTRATE THAT SEQUENTIAL COMPRESSION (MANUFACTURED BY KENDALL/COVIDIEN) IS ASSOCIATED WITH HIGH DVT RATES AND THAT THE CTC DEVICE IS SUPERIOR. THE STUDIES REFERENCED IN THIS PAPER ((B)(4)) ARE PERFORMED IN TOTAL JOINT REPLACEMENT (TJR) POPULATIONS, AND ARE UP TO 30 YEARS OLD, SOME CONDUCTED IN THE 1970'S, AND PUBLISHED IN 80'S AND 90'S. THIRTY YEARS AGO, TJR PT LENGTH OF STAY WAS MUCH LONGER THAN IT IS TODAY (UP TO 10 DAYS V. 2.5 DAYS), CHEMICAL PROPHYLAXIS WAS NOT COMMONPLACE, AND PTS WERE KEPT IMMOBILE FOR EXTENDED PERIODS OF TIME. THIS PLACED TJR PTS AT GREAT RISK FOR COMPLICATIONS, RESULTING IN VTE RATES UP TO (B)(4). THE "CLINICAL STUDIES" DOCUMENT THAT CTC PROMOTES AND PROVIDES TO HOSPITALS IN EFFORT TO CLINICALLY JUSTIFY THEIR PRODUCT IS A COMPLETE MISREPRESENTATION OF VTE RATES ASSOCIATED WITH SEQUENTIAL COMPRESSION. CTC WAS NOTIFIED ABOUT OUR INCREASED INCIDENCE OF DVT IN (B)(6) 2013, CTC RESPONDED BY ASKING US TO TRIAL THEIR "NEW" SEQUENTIAL "VASOGRAD" SLEEVES RATHER THAN SWITCHING VENDORS (BACK TO KENDALL/COVIDIEN). WHEN WE RECEIVED THE CTC SAMPLE VASOGRAD SLEEVES, WE TESTED THEM AND NOTED THAT THE SLEEVES DID NOT INFLATE ADEQUATELY. WE WENT ON TO FURTHER TEST THE SLEEVES BY CUTTING AWAY THE FABRIC AND OBSERVING THE ACTUAL ACTION OF THE INFLATION. WE CONFIRMED THAT THE AIR BLADDERS WITHIN THE SLEEVES DO NOT COMPLETELY INFLATE OR DO NOT INFLATE AT ALL ((B)(4)). EACH OF THE FOUR (4) VASOGRAD SAMPLES THAT CTC PROVIDED TO US FAILED. THE ADMINISTRATION OF (B)(6) WAS NOTIFIED REGARDING OUR HIGH INCIDENCE OF LOWER EXTREMITY DVT ASSOCIATED WITH THE NEW CTC DEVICE IN (B)(6) 2013. ADMINISTRATION ORDERED AN IMMEDIATE REMOVAL OF ALL CTC DEVICES WITHIN THE FACILITY WHICH WERE REPLACED WITH THE PRIOR VENDOR ((B)(4)). THE REPRESENTATIVES FOR CTC DENY ANY RESPONSIBILITY RELATED TO NEGATIVE PT OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156366 CTC VASOPRESS COMPRESSION SLEEVES CTC VASOPRESS DVT SYSTEM, COMPRESSION SLEEVE JOW CTC COMPRESSION THERAPY CONCEPTS THIGH/CALF/FOOT PUMP GARMENTS
    156367 CTC VASOGRAD DVT SEQUENTIAL SLEEVES CTC VASOPRESS DVT SYSTEM, SEQUENTIAL SLEEVE JOW CTC COMPRESSION THERAPY CONCEPTS THIGH/CALF/FOOT PUMP GARMENTS

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O| R| S
    10
    2
    3
    4
    5
    6
    7
    8
    9