BEUDAMED
    FDA Adverse Event Other Summary report: N

    CAREFUSION

    MDR report key: 3098837 · Received May 1, 2013

    Report

    Report Number
    2021710-2013-00030
    Event Type
    Other
    Date Received
    May 1, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K073069
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MFR. EVENT CODES WERE DERIVED BASED ON INFO DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION (S) WITH A USER FACILITY REP AND WRITTEN RESPONSES FROM THE USER FACILITY. (B)(4). THE FOLLOWING INFO CONCERNING THE EVALUATION OF THE DEVICE IS A SUMMARY OF THE INFO DOCUMENTED BY THE CAREFUSION TECH SUPPORT SPECIALIST AND INFO DOCUMENTED BY THE CAREFUSION FIELD SVC REP. THE ALLEGATION OF PT EXPIRATION WAS REPORTED TO HAVE OCCURRED AT ANOTHER FACILITY OTHER THAN THE FACILITY NAMED IN THIS REPORT. THERE IS A NO ALLEGATION OR INFO ALLEGING THAT CAREFUSION PRODUCTS OR MATERIALS WERE INVOLVED IN, OR CONTRIBUTED TO THE REPORTED EXPIRATION. A CAREFUSION FIELD SVC ENGINEER VISITED THE FACILITY NAMED IN THIS REPORT AND CONFIRMED THAT THE VENTILATOR IS PERFORMING PER RELEASED LABELING. A FOLLOW-UP REQUEST FROM CAREFUSION TO THE FACILITY NAMED IN THIS REPORT SEEKING ADD'L INFO WAS SENT TO THE INITIAL REPORTER. INFO ASSOCIATED WITH THE PT AND THE FACILITY NAME WHERE THE ALLEGED PT EXPIRATION OCCURRED HAS NOT BEEN PROVIDED AS OF (B)(4) 2013. SHOULD ADD'L INFO BECAME AVAILABLE A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH USER FACILITY REP(S) ON (B)(6) 2013. "THE CUSTOMER CONTACTED AFTER HOURS SUPPORT WITH APPARENT ISSUE'S RELATED TO USING VOLUME GUARANTEE FEATURE AND SOME NEGATIVE PT OUTCOMES (PULMONARY INTERSTITIAL EMPHYSEMA)/AIR LEAK SYNDROME) I PROVIDED SOME FEEDBACK PER OPERATORS MANUAL, THE CUSTOMER INDICATED SHE HAD CONTACTED FIELD CLINICAL OPS GROUP (NAME REMOVED) AND HE WOULD SCHEDULE CLINICAL VISIT. I SUGGESTED IF SHE COULD E-MAIL SOME VENT SPECIFIC SETTINGS WITH SN # ASSOCIATED WITH THIS ISSUE. I ALSO NOTED TO (NAME REMOVED) AN ON-SITE VISIT BY OUR FIELD REP WOULD BE ALSO RECOMMENDED TO ENSURE UNIT IS FUNCTIONING ACCORDINGLY. THE FOLLOWING ADD'L INFO CONCERNING THE EVENT AND THE CONDITION OF THE PT WAS COPIED FROM AN E-MAIL REC'D FROM THE USER FACILITY ON (B)(6) 2013. "I AM SENDING AN EMAIL IN RESPONSE TO OUR CONVERSATION TODAY REGARDING OUR CURRENT ISSUES WITH FIVE PT OUTCOMES OF PIE (PULMONARY INTERSTITIAL EMPHYSEMA)/AIR LEAK SYNDROME WHILE USING PSIMV/VG ON THE AVEA VENTILATOR, TWO OF WHICH RESULTED IN PTS EXPIRING. WE HAVE BEEN EXPLORING OUR INTERVENTIONS PRIOR TO THESE PTS BEING ON PSIMV/VG, BUT ARE ALSO CONSIDERING OUR VENT MANAGEMENT AND EFFECTIVENESS OF THE NEOLFLOW SENSOR IN GUARANTEEING VOLUME WITH THE ALARMS THAT WE HAVE ENCOUNTERED. ALARMS HAVE CONSISTED OF FREQUENT VTE (CONCERNING THAT THIS IS A MODERATE E NOT HIGH ALARM STATE AFTER 30 SECONDS) AND NOTED FREQUENT TO CONSTANT MESSAGING OF PRESSURE REGULATION VOLUME LIMITED, DESPITE A LEAK LESS THAN 60%, OUR PT'S HAVE SUFFERED FROM ATELECTRAUMA. ANOTHER COMMON FACTOR HAS BEEN AUTO-CYCLING OF RR'S OF 80-100 BPM, DESPITE EVERYTHING FROM PT TO VENT CHECKING OUT (NEOFLOW SENSOR ZEROED). IT HAS BEEN SUGGESTED THAT WE PERFORM A AVEA FLOW SENSOR HOT WIRE VERIFICATION TEST TO TEST THE EFFICIENCY AND/OR CLEANLINESS OF OUR CURRENT NEOFLOW SENSORS THAT ARE APPROXIMATELY 6 MONTHS OLD. TYPICAL VENT SETTINGS ARE AS FOLLOWS: VT 5-6ML/KG, PEEP5-6 CM H2O, ITIMES 0.35-0.40, PS 5-6 RRS 20-30 BPM. PEAK LIMIT 25-35 CMH2O DEPENDENT ON PT COMPLIANCE. (NAME REMOVED) HAS ALSO MADE ME AWARE OF SOME POSSIBLE ADJUSTMENTS TO OUR ADVANCED SETTINGS THAT MAY BE HELPFUL IN THIS MATTER. (NAME REMOVED) HOPES TO VISIT OUR FACILITY WITHIN THE NEXT WEEK TO ASSIST US. WE ARE CURRENTLY ONLY USING PSIMV UNTIL WE HAVE A BETTER PLAN ON HOW TO REAPPROACH OUR USE OF PSIMV/VG FOR BETTER PT OUTCOMES. WE HAVE 5 AVEA VENTILATORS THAT ARE PROGRAMMED FOR VOLUME GUARANTEE. TWO OF THE SERIAL NUMBERS THAT YOU REQUESTED ARE AS FOLLOWS (B)(4). I APPRECIATE YOUR TIME IN ASSISTING US WITH OUR VENTILATION CONCERNS." THE FOLLOWING ADD'L INFO CONCERNING THE EVENT AND THE CONDITION OF THE PT WAS COPIED FROM AN E-MAIL REC'D FROM THE USER FACILITY ON (B)(6) 2013 THAT WAS IN RESPONSE TO A LETTER SENT BY CAREFUSION SEEKING ADD'L INFO. "I RECENTLY REC'D INFO FROM OUR ATTENDING IN THE FORM OF A POWERPOINT PRESENTATION THAT DOES NOT INCLUDE PT NAMES. THERE WERE FOUR INSTANCES OF PIE, TWO OF WHICH EXPIRED. ALL FOUR CASES OF PIE WERE TRANSFERRED OUT OF OUR HOSPITAL, AND WE WERE LATER NOTIFIED OF THE TWO THAT EXPIRED AT THE OTHER FACILITY. I DO NOT HAVE THE ACTUAL VENTS THAT THE PTS' WERE ON, THAT WOULD TAKE SOME MORE INVESTIGATING, BUT COULD BE RETRIEVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190190 CAREFUSION VENTILATOR, CONFTINUOUS, FACILTY USE/CBK CBK CAREFUSION AVEA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ASKU