BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIV.A.C.® THERAPY

    MDR report key: 6141838 · Received December 2, 2016

    Report

    Report Number
    3009897021-2016-00102
    Event Type
    Injury
    Date Received
    December 2, 2016
    Date of Event
    November 2, 2016
    Report Date
    December 2, 2016
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    PMA / PMN Number
    K063692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON INFORMATION PROVIDED AND INVESTIGATION OF THE UNIT, THERE IS NO INDICATION V.A.C. THERAPY CONTRIBUTED TO THE AMOUNT OF BLOOD LOSS THE PATIENT HAD DURING THE ALLEGED BLEEDING EVENT. EVALUATION OF THE UNIT DID NOT REVEAL EVIDENCE OF AN OPERATIONAL MALFUNCTION. ADDITIONAL MEDICAL INFORMATION OBTAINED INDICATED THE PATIENT HAD MULTIPLE COMORBIDITIES, WAS ON ASPIRIN AT THE TIME OF THE EVENT, AND JUST DAYS PRIOR TO THE EVENT THE PHYSICIAN DISCONTINUED THE ANTICOAGULANT COUMADIN THE PATIENT WAS TAKING DUE TO A SUPRATHERAPEUTIC INR RESULTS. THE NURSE REPORTED THAT THE PATIENT HAS HAD CONTINUOUS HIGH INR LEVELS THROUGHOUT HIS TIME ON V.A.C. THERAPY WHICH WAS A CONTRIBUTING FACTOR TO THE BLEEDING EVENT. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: WITH OR WITHOUT USING V.A.C. THERAPY, CERTAIN PATIENTS ARE AT HIGH RISK OF BLEEDING COMPLICATIONS. THE FOLLOWING TYPES OF PATIENTS ARE AT INCREASED RISK OF BLEEDING, WHICH, IF UNCONTROLLED, COULD BE POTENTIALLY FATAL. PATIENTS WHO HAVE WEAKENED OR FRIABLE BLOOD VESSELS OR ORGANS IN OR AROUND THE WOUND AS A RESULT OF, BUT NOT LIMITED TO: SUTURING OF THE BLOOD VESSEL (NATIVE ANASTOMOSIS OR GRAFTS)/ORGAN INFECTION,TRAUMA, RADIATION. PATIENTS WITHOUT ADEQUATE WOUND HEMOSTASIS, PATIENTS WHO HAVE BEEN ADMINISTERED ANTICOAGULANTS OR PLATELET AGGREGATION INHIBITORS, PATIENTS WHO DO NOT HAVE ADEQUATE TISSUE COVERAGE OVER VASCULAR STRUCTURES. IF V.A.C. THERAPY IS PRESCRIBED FOR PATIENTS WHO HAVE AN INCREASED RISK OF BLEEDING COMPLICATIONS, THEY SHOULD BE TREATED AND MONITORED IN A CARE SETTING DEEMED APPROPRIATE BY THE TREATING PHYSICIAN. IF ACTIVE BLEEDING DEVELOPS SUDDENLY OR IN LARGE AMOUNTS DURING V.A.C. THERAPY, OR IF FRANK (BRIGHT RED) BLOOD IS SEEN IN THE TUBING OR IN THE CANISTER, IMMEDIATELY STOP V.A.C. THERAPY, LEAVE DRESSING IN PLACE, TAKE MEASURES TO STOP THE BLEEDING AND SEEK IMMEDIATE MEDICAL ASSISTANCE. THE V.A.C. THERAPY UNITS AND DRESSINGS SHOULD NOT BE USED TO PREVENT, MINIMIZE OR STOP VASCULAR BLEEDING. · PROTECT VESSELS AND ORGANS: ALL EXPOSED OR SUPERFICIAL VESSELS AND ORGANS IN OR AROUND THE WOUND MUST BE COMPLETELY COVERED AND PROTECTED PRIOR TO THE ADMINISTRATION OF V.A.C. THERAPY. 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. WARNINGS PROTECT VESSELS AND ORGANS: ALL EXPOSED OR SUPERFICIAL VESSELS AND ORGANS IN OR AROUND THE WOUND MUST BE COMPLETELY COVERED AND PROTECTED PRIOR TO THE ADMINISTRATION OF V.A.C. THERAPY. ALWAYS ENSURE THAT V.A.C. FOAM DRESSINGS DO NOT COME IN CONTACT WITH VESSELS OR ORGANS. USE A THICK LAYER OF NATURAL TISSUE SHOULD PROVIDE THE MOST EFFECTIVE PROTECTION. IF A THICK LAYER OF NATURAL TISSUE IS NOT AVAILABLE OR IS NOT SURGICALLY POSSIBLE, BIOENGINEERED TISSUE OR MULTIPLE LAYERS OF NON-ADHERENT DRESSING MATERIAL MAY BE CONSIDERED AS AN ALTERNATIVE, IF DEEMED BY THE TREATING PHYSICIAN TO PROVIDE A COMPLETE PROTECTIVE BARRIER. IF USING NON-ADHERENT MATERIALS, ENSURE THEY ARE SECURED IN A MANNER THAT WILL MAINTAIN THEIR PROTECTIVE POSITION THROUGHOUT THERAPY. CONSIDERATION SHOULD ALSO BE GIVEN TO THE NEGATIVE PRESSURE SETTING AND THERAPY MODE WHEN USED WHEN INITIATING THERAPY. CAUTION SHOULD BE TAKEN WHEN TREATING LARGE WOUNDS THAT MAY CONTAIN HIDDEN VESSELS WHICH MAY NOT BE READILY APPARENT. THE PATIENT SHOULD BE CLOSELY MONITORED FOR BLEEDING IN A CARE SETTING DEEMED APPROPRIATE BY THE TREATING PHYSICIAN.

    Description of Event or Problem · 1

    ON NOV 02 2016, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT'S CAREGIVER: THE PATIENT'S UNIT WAS ALARMING BLOCKAGE AND THE PATIENT WAS ALLEGEDLY SENT TO THE HOSPITAL FOR ISSUES WITH THE DRESSING. ON NOV 07 2016, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE NURSE: THE PATIENT WAS SENT TO THE HOSPITAL AND A SUTURE WAS PLACED IN THE WOUND IN ORDER TO STOP BLEEDING THAT HAD OCCURRED IN THE WOUND. THE BLOCKAGE ALARMS WERE RESOLVED AFTER THE BLEEDING WAS RESOLVED. THE BLOCKAGES WERE CAUSED BY CLOTS FROM THE BLEEDING EVENT. THE PATIENT IS NOW AT HOME AND THERE HAVE BEEN NO FURTHER REPORTED ISSUES. ON DEC 1 2016, THE FOLLOWING INFORMATION WAS IDENTIFIED BY KCI AFTER COMPLETING A REVIEW OF THE SURGEON'S PROGRESS REPORT RECEIVED: PATIENT HAD A HISTORY OF ATRIAL FIBRILLATION. THE PATIENT HAD BEEN HAVING INTERMITTENT ATRIAL FIBRILLATION AND WAS ON ANTICOAGULATION WITH COUMADIN. THE PATIENT'S INR [INTERNATIONAL NORMALIZED RATIO A CALCULATION MADE TO STANDARDIZE PROTHROMBIN TIME] WAS SUPRATHERAPEUTIC [ADMINISTERED AT LEVELS GREATER THAN WOULD BE USED IN ACTUAL TREATMENT OF A MEDICAL CONDITION]. THE COUMADIN WAS PLACED ON HOLD. ON DEC 2 2016, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE NURSE: THE PATIENT WAS SEEN A FEW DAYS LATER FOLLOWING THE EVENT AND THE WOUND ASSESSED. THERE WAS NO ACTIVE BLEEDING SEEN FROM THE WOUND AT THE TIME OF THE ASSESSMENT AND ACTIV.A.C. THERAPY WAS RESTARTED. THE PATIENT HAS HAD CONTINUAL HIGH INR LEVELS THROUGHOUT HIS TIME ON ACTIV.A.C. THERAPY AND THIS COULD HAVE BEEN ONE OF THE CONTRIBUTING FACTORS TO THE BLEEDING EVENT. SHE DID NOT RULE OUT ACTIV.A.C. THERAPY AS POSSIBLY CONTRIBUTING TO THE EVENT. THERE HAS BEEN NO FURTHER BLEEDING EVENTS AND THE PATIENT CONTINUES ON ACTIV.A.C. THERAPY AT THIS TIME. ON OCT 13 2016, THE DEVICE WAS TESTED PER QUALITY CONTROL (QC) PROCEDURE BY KCI FIELD SERVICE, AND THE UNIT PASSED THE QC CHECKS AND MET SPECIFICATIONS. ON (B)(6) 2016, THE DEVICE WAS PLACED WITH THE PATIENT. ON NOV 30 2016, THE DEVICE WAS TESTED PER QUALITY CONTROL (QC) PROCEDURE BY KCI QUALITY ENGINEERING, AND THE UNIT PASSED THE QC CHECKS AND MET SPECIFICATIONS. INSPECTION AND TESTING OF THE DEVICE DID NOT REVEAL ANY EVIDENCE OF AN OPERATIONAL MALFUNCTION WITH THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792122 ACTIV.A.C.® THERAPY OMP OMP KCI USA, INC. WNDACT

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention ACETAMINOPHEN 650MG FOR PAIN| ALBUTEROL INHALER AS NEEDED| ARIPIPRAZOLE 10MG 1/2 TABLET AT BEDTIME| ASPIRIN 81MG ONCE DAILY| BENZOLAMIDE OPHTHALMIC 1% EVERY 12HRS| CARVEDILOL 3.125 MG| FOUROSEMIDE 20MG| GLUCAGON KIT| INSULIN LEVEMIR 6 UNITS AT BEDTIME| INSULIN NOVOLOG 10 UNITS WITH BREAKFAST| INSULIN NOVOLOG 4 UNITS WITH LUNCH| INSULIN NOVOLOG 5 UNITS WITH SUPPER| LATANOPROST OPHTHALMIC .005% DAILY| LEVOTHYROXINE 75MCG DAILY| MAGNESIUM OXIDE 400 MG 2 TIMES A DAY| METFORMIN 500MG 2 TABLETS TWICE A DAY| POLYETHYLINE GLYCOL AS NEEDED| PROVASTATIN 40MG DAILY| ROPINIROLE 3MG DAILY| TOPICAL KETOCONAZOLE2% CREAM| TRAMADOL 50 MG EVERY 8 HOURS AS NEEDED| VENLAXINE 75 MG DAILY| WARFARIN 4MG 1.5 TABLETS ON ALL OTHER DAYS| WARFARIN 4MG 2 TABLETS ON MONDAYS