BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY

    MDR report key: 2003613 · Received February 22, 2011

    Report

    Report Number
    1625774-2011-00025
    Event Type
    Injury
    Date Received
    February 22, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 25, 2011
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS TESTED PER QUALITY CONTROL (QC) PROCEDURES BY A KCI FIELD SERVICE EMPLOYEE ON (B)(6) 2010, PRIOR TO PLACEMENT WITH THE PT. THE UNIT PASSED QC CHECKS AND MET SPECIFICATIONS. TESTING AND EVAL OF THE UNIT AFTER THE PLACEMENT DID NOT REVEAL ANY EVIDENCE OF AN OPERATIONAL MALFUNCTION. THERE WAS NO INDICATION OF DAMAGE TO THE UNIT'S POWER PORT AND THE POWER SUPPLY ADAPTER WITH CORD PLUGGED INTO THE UNIT SECURELY, AS DESIGNED. THE POWER SUPPLY ADAPTER DID NOT DISENGAGE FROM THE UNIT DURING THE DEVICE EVAL. THE UNIT WAS TESTED ON BATTERY MODE FOR 6 HOURS TO TEST THE ALARM FUNCTION AND THE UNIT DID ALARM BATTERY CRITICAL AS DESIGNED. WE ARE FILING THIS REPORT BECAUSE A POSSIBLE CONTRIBUTION DUE TO USE ERROR CANNOT BE ENTIRELY RULED OUT DUE TO LIMITED INFO PROVIDED. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE: KEEP VAC THERAPY ON FOR AT LEAST 22 HOURS IN A 24 HOUR PERIOD. DO NOT LEAVE THE VAC DRESSING IN PLACE IF THE THERAPY UNIT IS SWITCHED OFF FOR MORE THAN 2 HOURS IN 24 HOURS. MONITOR CONTINUOUSLY AND CHECK AND RESPOND TO ALARMS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO KCI BY THE PT'S FAMILY MEMBER: THE V.A.C. THERAPY UNIT'S POWER CORD BECAME LOOSE AND DID NOT PROVIDE THERAPY. ON (B)(6) 2010, PER THE NURSES NOTES, IT WAS DOCUMENTED THAT THE PT WAS SHOWING SIGNS OF INADEQUATE INTAKE, POOR SKIN TURGOR, DARK URINE, WOUND ODOR, MODERATE DRAINAGE, AND YELLOW SLOUGH IN BOTH WOUNDS. THE PERIWOUND SKIN ON BOTH WOUNDS WAS NOTED TO BE BRIGHT RED WITH BLANCHING. ON (B)(6) 2011, THE HOME HEALTH NURSE CHANGED THE V.A.C. DRESSING AND NOTED THAT THERE WAS A FOUL ODOR AND BOTH WOUNDS WERE COVERED WITH SLOUGH. THE V.A.C. THERAPY UNIT'S HISTORY LOG WAS LATER CHECKED AND IT WAS NOTED THAT THE UNIT HAD BEEN OFF SINCE (B)(6) 2011. THE V.A.C. DRESSING WAS CHANGED TO A WET TO DRY DRESSING AND THE PT WAS ADMITTED TO THE HOSPITAL. ON (B)(6) 2011, THE DOCTOR'S NOTES INDICATE POSSIBLE INFECTION IN BOTH HIP WOUNDS. THE CAUSE OF THE INFECTION WAS UNK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R