BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY SYSTEM

    MDR report key: 2041974 · Received March 31, 2011

    Report

    Report Number
    1625774-2011-00042
    Event Type
    Injury
    Date Received
    March 31, 2011
    Date of Event
    February 15, 2011
    Report Date
    March 2, 2011
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE FILING THIS REPORT BECAUSE A POSSIBLE CONTRIBUTION DUE TO USE ERROR CANNOT BE ENTIRELY RULED OUT DUE TO LIMITED INFO PROVIDED. THE TREATING SURGEON HAS DECLINED TO PROVIDE ADD'L INFO REGARDING THE REPORTED EVENT. THE UNIT WAS TESTED PER QUALITY CONTROL (QC) PROCEDURES BY A KCI QA SPECIALIST IN (B)(4) ON (B)(4) 2011. THE UNIT PASSED QC CHECKS AND MET SPECIFICATIONS. THE DEVICE WAS PLACED WITH THE PATIENT ON (B)(4) 2011. THE UNIT WAS RETURNED TO KCI IN (B)(4) ON (B)(4) 2011 THEN RECEIVED IN KCI QUALITY ENGINEERING ON (B)(4) 2011 FOR DEVICE EVALUATION. THE POWER CORD AND POWER SUPPLY ADAPTER WERE RETURNED WITH THE DEVICE. INSPECTION, TESTING AND EVALUATION OF THE UNIT DID NOT REVEAL ANY EVIDENCE OF AN OPERATIONAL MALFUNCTION OR DEFECT WITH THE DEVICE. THE UNIT WORKED PROPERLY, AS DESIGNED, AND PASSED THE FLOW SENSOR CHECK, PRESSURE ACCURACY CHECK AND ALARM FUNCTIONS. THE UNIT PASSED QC CHECKS AND MET SPECIFICATIONS BEFORE AND AFTER PLACEMENT WITH THE PATIENT.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE WOUND CARE NURSE: ON (B)(6) 2011, REPORT WAS RECEIVED FROM AUSTRALIA OF A PATIENT WHO HAD BEEN ON V.A.C. THERAPY FOR 6 WEEKS FOLLOWING AN ABOVE THE KNEE AMPUTATION. THE PATIENT WAS IN A LONG TERM CARE FACILITY AND HAD V.A.C. DRESSING CHANGED ON (B)(6) 2011. AFTER THE DRESSING CHANGE THE PATIENT WAS PUT TO BED SOMETIME AFTER NOON AND WAS IN STABLE CONDITION. LATER THAT AFTERNOON, THE NURSING STAFF NOTICED BLOOD ON THE FLOOR. NURSE CHECKED ON THE PATIENT AND FOUND HER WITH DIFFICULT RESPIRATIONS, NO BLOOD PRESSURE OR PULSE. ADDITIONAL INFORMATION (B)(6) 2011, EMERGENCY PERSONNEL RESPONDED. COMPRESSION BANDAGE AND ICE PACKS WERE APPLIED TO THE WOUND. THE FAMILY REQUESTED NO ACTIVE RESUSCITATION, BUT AGREED TO FLUID REPLACEMENT; HOWEVER THE NURSING STAFF WAS UNABLE TO GET AN INTRAVENOUS ACCESS. THE PATIENT EXPIRED AT 1530. NO FURTHER INFORMATION IS AVAILABLE.

    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 88 YR Life Threatening| O| R WARFARIN 1MG-1.5MG ALTERNATING