BEUDAMED
    FDA Adverse Event Death Summary report: N

    V.A.C. THERAPY SYSTEM

    MDR report key: 2167201 · Received July 13, 2011

    Report

    Report Number
    1625774-2011-00088
    Event Type
    Death
    Date Received
    July 13, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 14, 2011
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS TESTED PER QUALITY CONTROL (QC) PROCEDURES BY A KCI FIELD SERVICE EMPLOYEE ON (B)(6) 2011. THE UNIT PASSED QC CHECKS AND MET SPECIFICATIONS. THE DEVICE WAS PLACED WITH THE PT ON (B)(6) 2011. THE UNIT WAS RETURNED TO KCI ON (B)(6) 2011 FOR DEVICE EVAL. INSPECTION, TESTING AND EVAL OF THE UNIT DID NOT REVEAL ANY EVIDENCE OF AN OPERATIONAL MALFUNCTION OR DEFECT WITH THE DEVICE. KCI IS FILING DUE TO POTENTIAL USER ERROR.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE DIRECTOR OF NURSES OF (B)(6) HOSPITAL REHAB REPORTED: ON (B)(6) 2011, THE PHYSICIAN WROTE AN ORDER TO RE-START V.A.C. THERAPY. ON (B)(6) 2011, AFTER 7 P.M. V.A.C. THERAPY WAS RE-STARTED. AT UNK TIMES, THE NIGHT NURSE CHECKED ON THE PT THROUGHOUT THE NIGHT DUE TO V.A.C. THERAPY BEEPING. THE CANISTER WAS CHANGED AND THE NURSE DID NOT NOTICE ANYTHING UNUSUAL. ON (B)(6) 2011, AT APPROX 6:58 AM, THE PT WAS ASSESSED AND WAS FOUND TO BE UNRESPONSIVE AND WAS NOTED TO HAVE BRIGHT, RED BLOOD IN THE V.A.C. TUBING. LIFE SUPPORT MEASURES WERE INITIATED, THE GRANUFOAM DRESSING WAS LEFT IN PLACE AND PRESSURE WAS APPLIED. THE PT WAS TRANSPORTED TO (B)(6) HOSPITAL IN UNK CONDITION AND SUBSEQUENTLY EXPIRED. NO OTHER INFO IS CURRENTLY AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death