BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY SYSTEM

    MDR report key: 1971481 · Received January 21, 2011

    Report

    Report Number
    1625774-2011-00004
    Event Type
    Injury
    Date Received
    January 21, 2011
    Date of Event
    December 22, 2010
    Report Date
    December 22, 2010
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    PMA / PMN Number
    K063692
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE THERAPY UNIT WAS RETURNED TO KCI SERVICE CTR AND TESTED PER QUALITY CONTROL PROCEDURES AND MET SPECS. THE PRESSURE ALERTS WERE NOT DUPLICATED. THE HISTORY LOG REVEALS THREE OCCASIONS, (B)(6) 2010, (B)(6) 2010, AND (B)(6) 2010, WHERE THE UNIT WAS MANUALLY TURNED OFF AND THERAPY WAS INACTIVE FOR MORE THAN 6 HOURS. ON (B)(6) 2010 THROUGH (B)(6) 2010, THERAPY OFF PRESSURE ALERTS OCCURRED, DELAYING THERAPY FOR APPROX FOUR HOURS. THE CONTROL MODULE WAS BEING REPLACED DUE TO THE INTERMITTENT MALFUNCTION OF THE PRESSURE FLUCTUATIONS. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES NEVER LEAVE A V.A.C. DRESSING IN PLACE WITHOUT ACTIVE V.A.C. THERAPY FOR MORE THAN 2 HOURS. IF THERAPY IS OFF FOR MORE THAN 2 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 ALTERNATIVE DRESSING, SUCH AS A WET TO MOIST GAUZE, AS APPROVED DURING TIMES OF EXTREME NEED, BY TREATING CLINICIAN.

    Description of Event or Problem · 1

    THE FOLLOWING INFO WAS REPORTED TO KCI BY THE HOME HEALTH NURSE: ON (B)(6) 2010, THE PT WAS PLACED ON ACTIV.A.C. THERAPY. ON (B)(6) 2010, THE HOME HEALTH NURSE REPORTED THAT THE PT'S LEFT AXILLA WOUND HAD INCREASED IN SIZE. THE ORIGINAL SIZE OF THE WOUND ON (B)(6) 2010, LENGTH: 3 CM, WIDTH: 2 CM, DEPTH: 4 CM. ON (B)(6) 2010, THE WOUND MEASUREMENTS WERE LENGTH: .8 WIDTH: .6, DEPTH: 2.80 AND THE WOUND WAS IMPROVING. ON (B)(6) 2010, THE WOUND MEASUREMENT WAS LENGTH: 1.40, WIDTH: .90, DEPTH: 2.80. ON THREE DIFFERENT OCCASIONS, THE ACTIVAC WAS TURNING OFF. BETWEEN (B)(6) 2010, THERE WERE FLUCTUATING PRESSURES WHEN THE UNIT WAS ON. AFTER THE (B)(6) 2010, THE ACTIV.A.C. WAS EXCHANGED WITH ANOTHER ONE. ON (B)(6) 2011, THE HOME HEALTH NURSE REPORTED THAT SINCE THE NEW ACTIVAC WAS PLACED, THE PT'S WOUND WAS IMPROVING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention