BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIV.A.C.® THERAPY

    MDR report key: 6194724 · Received December 21, 2016

    Report

    Report Number
    3009897021-2016-00115
    Event Type
    Injury
    Date Received
    December 21, 2016
    Date of Event
    November 22, 2016
    Report Date
    December 21, 2016
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    PMA / PMN Number
    K063692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED NECROSIS TO THE WOUND IS RELATED TO V.A.C. THERAPY. THE WOUND CARE NURSE STATED, "THE WOUND NECROSIS FOUND IN THE PATIENT'S WOUND WAS CAUSED BY A PATIENT USE ERROR. THE PATIENT WAS TURNING OFF THE UNIT AND NOT CHARGING THE UNIT PROPERLY LETTING IT RUN OUT OF POWER RESULTING IN THE PATIENT BEING WITHOUT THERAPY FOR LONG PERIODS OF TIME." THEREFORE, KCI HAS DETERMINED THIS EVENT IS REPORTABLE DUE TO POSSIBLE USE ERROR. DEVICE LABELING, AVAILABLE IN PRINT, STATES: PATIENTS RECEIVING V.A.C. THERAPY MAY EXPERIENCE A REDUCTION IN PAIN AS THE WOUND BEGINS TO HEAL. HOWEVER, SOME PATIENTS EXPERIENCE DISCOMFORT DURING TREATMENT OR DRESSING CHANGES. IN LINE WITH INSTITUTIONAL GUIDELINES, A VALIDATED PAIN SCORING TOO SHOULD BE USED AND PAIN SCORES SHOULD BE DISCONTINUED WHERE APPROPRIATE BEFORE, DURING AND AFTER DRESSING-RELATED PROCEDURES. IN ADDITION, THE FOLLOWING STRATEGIES SHOULD BE CONSIDERED: -IF THE PATIENT COMPLAINS OF DISCOMFORT THROUGHOUT THERAPY, CONSIDER CHANGING TO V.A.C. WHITEFOAM DRESSING. -ENSURE THE PATIENT RECEIVES ADEQUATE ANALGESIA DURING TREATMENT. -IF THE PATIENT COMPLAINS OF DISCOMFORT DURING THE DRESSING CHANGE, CONSIDER PREMEDICATION, THE USE OF A NON-ADHERENT LAYER BEFORE FOAM PLACEMENT, USING V.A.C. WHITEFOAM TO DRESS THE WOUND, OR MANAGING THE DISCOMFORT AS PRESCRIBED BY THE TREATING PHYSICIAN. -A SUDDEN INCREASE OR CHANGE IN THE CHARACTER OF THE PAIN REQUIRES INVESTIGATION. 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: -CHECK THE THERAPY HOUR METER TO ENSURE THAT 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 · 1

    ON NOV 22 2016, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE NURSE: THE PATIENT ALLEGEDLY HAD NECROTIC TISSUE FROM THE UNIT BEING AT A PRESSURE OF 200 MMHG. ON DEC 20 2016, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE PHYSICIAN'S WOUND CARE CENTER NURSE: ON NOV 22 2016 THE HOME HEALTH NURSE INFORMED THE PHYSICIAN THAT THE PATIENT HAD NECROTIC TISSUE IN THE WOUND FROM THE PRESSURE SETTINGS BEING AT 200 MMHG. THE PHYSICIAN SAW THE PATIENT AND AT THE TIME OF WOUND ASSESSMENT FOUND NECROTIC TISSUE IN THE WOUND BED. THE PHYSICIAN QUESTIONED THE PATIENT AND WAS ABLE TO DETERMINE THE PATIENT HAD NOT BEEN CHARGING THE UNIT PROPERLY AND WOULD LET THE UNIT RUN OUT OF POWER. THE PATIENT WAS ALSO TURNING THE UNIT OFF HERSELF AND WOULD NOT CHANGE HER DRESSING TO AN ALTERNATE DRESSING AS PRESCRIBED BY THE PHYSICIAN. THE PATIENT WOULD BE WITHOUT THERAPY FOR LONG PERIODS OF TIME WITH THE DRESSING REMAINING IN PLACE. THE PHYSICIAN PLACED THE PATIENT ON AN ALTERNATE DRESSING AND THE NECROTIC TISSUE RESOLVED ON ITS OWN WITHOUT ANY SURGICAL INTERVENTION REQUIRED. THE PATIENT'S WOUND IS DOING GREAT AND MAKING PROGRESS AT THIS TIME. THE PHYSICIAN DISCHARGED THE PATIENT FROM V.A.C. THERAPY BECAUSE SHE WOULD NOT FOLLOW-UP INSTRUCTIONS AND HIS PLAN OF CARE WITH THE USE OF V.A.C. THERAPY. ON OCT 14 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 DEC 20 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 TO CONFIRM THE CUSTOMER COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845254 ACTIV.A.C.® THERAPY OMP OMP KCI USA, INC. WNDACT

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other