ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM

Report

Report Number: 3009897021-2021-00277
Event Type: Injury
Date Received: December 13, 2021
Date of Event: October 21, 2021
Report Date: December 13, 2021
Manufacturer: KINETIC CONCEPTS, INC.
Product Code: OMP
UDI-DI: 00849554005600
PMA / PMN Number: K201571
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

BASED ON THE INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED SKIN BREAKDOWN AND MACERATION REQUIRING EXCISIONAL DEBRIDEMENT ARE RELATED TO THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM. THE PATIENT HAS SEVERE CARDIAC DISEASE WITH LOWER EXTREMITY EDEMA AND HAS BEEN NON-COMPLIANT WITH HIS CARDIAC MEDICATION REGIMEN. THE PATIENT REPORTED THAT THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM STOPPED WORKING AND THE V.A.C.® DRESSING WAS LEFT IN PLACE OVER THE MANUFACTURER'S RECOMMENDATIONS. THE WOUND CARE NURSE MANAGER CONFIRMED THE PATIENT REPEATEDLY REMOVED V.A.C.® THERAPY WITHOUT CONTACTING THE PHYSICIAN. THIS EVENT IS BEING REPORTED DUE TO POTENTIAL USE ERROR. THE DEVICE PASSED QUALITY CONTROL CHECKS BEFORE AND AFTER PLACEMENT. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: WARNING: NEVER LEAVE A V.A.C.® DRESSING IN PLACE WITHOUT ACTIVE V.A.C.® THERAPY FOR MORE THAN TWO HOURS. IF THERAPY IS OFF FOR MORE THAN TWO HOURS, REMOVE THE OLD DRESSING AND IRRIGATE THE WOUND. EITHER APPLY A NEW V.A.C.® DRESSING FROM AN UNOPENED STERILE PACKAGE AND RESTART V.A.C.® THERAPY; OR APPLY AN ALTERNATE DRESSING, SUCH AS A WET TO MOIST GAUZE, AS APPROVED DURING TIMES OF EXTREME NEED, BY TREATING PHYSICIAN. DRESSING CHANGES: WOUNDS BEING TREATED WITH THE V.A.C.® THERAPY SYSTEM SHOULD BE MONITORED ON A REGULAR BASIS. IN A MONITORED, NON-INFECTED WOUND, V.A.C.® DRESSINGS SHOULD BE CHANGED EVERY 48-72 HOURS, BUT NO LESS THAN 3 TIMES A WEEK, WITH FREQUENCY ADJUSTED BY THE CLINICIAN AS APPROPRIATE. INFECTED WOUNDS MUST BE MONITORED OFTEN AND VERY CLOSELY. FOR THESE WOUNDS, DRESSINGS MAY NEED TO BE CHANGED MORE OFTEN THAN 48-72 HOURS; THE DRESSING CHANGING INTERVALS SHOULD BE BASED ON A CONTINUING EVALUATION OF THE WOUND CONDITION AND THE PATIENT'S CLINICAL PRESENTATION, RATHER THAN A FIXED SCHEDULE. FOOT WOUNDS: FOR WOUNDS ON THE PLANTAR SURFACE OR HEEL OF THE FOOT, IT IS BEST TO USE A BRIDGING TECHNIQUE TO ENSURE THAT ADDITIONAL PRESSURE IS NOT APPLIED AS A CONSEQUENCE OF THE PLACEMENT OF THE TUBING AND / OR SENSAT.R.A.C.¿ PAD. THIS INVOLVES USING FOAM TO ALLOW PLACEMENT OF THE SENSAT.R.A.C.¿ PAD OR TUBING ON THE DORSUM OF THE FOOT. APPROPRIATE OFF-LOADING OF THE FOOT IS ESSENTIAL IN ORDER TO MAXIMIZE THE THERAPEUTIC BENEFIT OF V.A.C.® THERAPY. DETERIORATION OF THE WOUND: IF A WOUND HAS BEEN PROGRESSING WELL FROM DRESSING CHANGE TO DRESSING CHANGE BUT THEN DETERIORATES RAPIDLY, CONSIDER THE FOLLOWING INTERVENTIONS AND, WHERE NECESSARY, SEEK THE GUIDANCE / EXPERTISE OF A SPECIALIST: IF AVAILABLE ON THE THERAPY UNIT, CHECK THE THERAPY HISTORY LOG TO ENSURE THE ACTUAL NUMBER OF THERAPY HOURS RECEIVED MATCHES THE NUMBER OF RECOMMENDED THERAPY HOURS (22 HOURS A DAY). IF THE NUMBER OF THERAPY HOURS IS LESS THAN 22 EACH DAY, FIND OUT WHY THERE IS A THERAPY DEFICIT AND REMEDY THE SITUATION. CLEAN WOUND MORE THOROUGHLY DURING DRESSING CHANGES. EVALUATE FOR SIGNS AND SYMPTOMS OF INFECTION AND, IF PRESENT, TREAT ACCORDINGLY. CHANGE DRESSING OFTEN, ENSURING THAT IT IS BEING CHANGED AT LEAST EVERY 48 HOURS. EXAMINE THE WOUND AND DEBRIDE AS NECESSARY. DEBRIDE THE WOUND EDGES IF THEY APPEAR NON-VIABLE OR ROLLED UNDER AS THIS MAY INHIBIT THE FORMATION OF GRANULATION TISSUE AND MIGRATION OF EPITHELIAL CELLS OVER AN ACCEPTABLE WOUND BASE.

Description of Event or Problem · 0

ON 16-NOV-2021, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT'S FAMILY MEMBER: THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM WAS DISCONTINUED ALLEGEDLY DUE TO MAKING THE WOUND WORSE. V.A.C.® THERAPY WAS ONLY USED FOR 8 HOURS THE TWO TIMES IT WAS ATTEMPTED. ON 16-NOV-2021, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE WOUND CARE CENTER NURSE MANAGER: THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM WAS REMOVED ALLEGEDLY DUE TO BREAKDOWN OF DORSAL SKIN AND MACERATION OF THE WOUND. THE PATIENT CARE MANAGER WAS UNABLE TO VERIFY V.A.C.® USAGE DUE TO PATIENT REPEATEDLY REMOVING THE V.A.C.® WITHOUT CONTACTING THE PHYSICIAN. ON 16-NOV-2021, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE HOME HEALTH NURSE SUPERVISOR: THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM WAS USED FOR LESS THAN 24 HOURS. ON 17-NOV-2021, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE WOUND CARE CENTER NURSE MANAGER: V.A.C.® THERAPY WAS PLACED ON (B)(6)2021, AND THE PATIENT WAS SEEN IN OFFICE ON (B)(6)2021. PATIENT STATED THE V.A.C.® STOPPED WORKING, AND THE DRESSING WAS LEFT IN PLACE. THE PATIENT SHOWERED AND THE DRESSING GOT WET. WOUND HAD SIGNIFICANT MACERATION. WOUND WAS DEBRIDED. PATIENT WAS SEEN AGAIN ON (B)(6) 2021 AND MACERATION STILL PRESENT BUT GREATLY IMPROVED, WOUND DEBRIDED. V.A.C.® REMAINED OFF AND PATIENT REMAINED ON ALTERNATIVE DRESSING. PATIENT SEEN AGAIN ON (B)(6)2021, AFTER HAVING HOME HEALTH PLACE THE V.A.C.® BACK ON (B)(6) 2021, AND WOUND WAS AGAIN MACERATED. WOUND DEBRIDED AND V.A.C.® DISCONTINUED. ON 17-NOV-2021, CLINICAL RECORDS FROM THE WOUND CARE CENTER WERE RECEIVED BY KCI WHICH NOTED THE FOLLOWING: PATIENT WAS DISCHARGED HOME YESTERDAY FROM HOSPITAL ON (B)(6)2021 WITH A WOUND V.A.C.® AND IV ANTIBIOTICS. PATIENT STATES THE V.A.C.® STOPPED WORKING OVERNIGHT, BUT THEY KEPT THAT DRESSING ON. PATIENT ALSO STATES THE DRESSING GOT WET IN THE SHOWER LAST NIGHT. PATIENT PRESENTS TODAY, (B)(6) 2021, WITH SIGNIFICANT MACERATION OF RIGHT FOOT SURGICAL SITE AND PERIWOUND OF THE OPEN ULCER. MULTIPLE SUTURES REMOVED AND MACERATED SURROUNDING TISSUE EXCISED. MULTIPLE BLISTERS DRAINED OVER THE DORSUM OF THE FOOT. WILL TAKE A BREAK FROM THE V.A.C.® DUE TO MACERATION, WORSENING OF THE WOUND, AND NON-COMPLIANCE FROM PATIENT. PATIENT WAS SEEN FOR FOLLOW UP ON (B)(6) 2021 WITH GOOD IMPROVEMENT OVER THE LAST WEEK. PREVIOUS MACERATION, EDEMA AND ERYTHEMA HAS ALMOST RESOLVED. HOME HEALTH WILL REAPPLY THE V.A.C.® ON (B)(6) 2021, THE DAY PRIOR TO PATIENT'S NEXT FOLLOW UP. ON (B)(6) 2021, PATIENT PRESENTS TO WOUND CARE CENTER. HOME HEALTH REAPPLIED THE V.A.C.® TO THE RIGHT FOOT YESTERDAY AFTERNOON. PATIENT HAS AGAIN DEVELOPED BREAKDOWN OF THE DORSAL SKIN AS WELL AS SOME MACERATION OF THE WOUND. WILL STOP V.A.C.® TREATMENT AS PATIENT HAS BEEN UNABLE TO TOLERATE ON MULTIPLE ATTEMPTS. DEEP DEBRIDEMENT PERFORMED. ON 07-DEC-2021, A DEVICE EVALUATION WAS COMPLETED BY KCI QUALITY ENGINEERING. ON 19-OCT-2021, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY KCI SERVICE CENTER, AND THE UNIT PASSED THE QUALITY CONTROL CHECKS AND MET SPECIFICATIONS. ON (B)(6)2021, THE DEVICE WAS PLACED WITH THE PATIENT. ON 09-NOV-2021, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY KCI SERVICE CENTER, AND THE UNIT PASSED THE QUALITY CONTROL CHECKS AND MET SPECIFICATIONS. INSPECTION AND TESTING OF THE DEVICE DID NOT REVEAL ANY EVIDENCE OF AN OPERATIONAL MALFUNCTION WITH THE UNIT. THE ALLEGED MACERATION AND WORSENING OF THE WOUND ON (B)(6) 2021 . THE ALLEGED SKIN BREAKDOWN AND MACERATION ON (B)(6)2021 IS REPORTED UNDER MDR-3009897021-2021-00289.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1883979	ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM	OMP	OMP	KINETIC CONCEPTS, INC.	WNDARM		00849554005600

Patients

Seq	Age	Sex	Outcome	Treatment
1	49 YR	Male	Required Intervention	ASPRIRIN 325 MG ORAL DAILY\| CARVEDILOL 12.5 MG ORAL TWICE DAILY\| CEFTRIAXONE 2 GM IV DAILY\| ENOXAPARIN 40 SC DAILY\| FUROSEMIDE 80 MG ORAL DAILY\| GLARGINE 60 UNITS SC TWICE DAILY\| LACTOBACILLUS TWO CAPSULES DAILY\| LISINOPRIL 2.5 MG ORAL DAILY\| LISPRO 20 UNITS SC WITH DINNER\| LISPRO 30 UNITS SC WITH BREAKFAST AND LUNCH\| LISPRO INSULIN SLIDING SCALE COVERAGE\| PANTOPRAZOLE 40 MG ORAL DAILY\| SPIRONOLACTONE 25 MG ORAL DAILY