BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY SYSTEM

    MDR report key: 1370855 · Received April 28, 2009

    Report

    Report Number
    1625774-2009-00042
    Event Type
    Injury
    Date Received
    April 28, 2009
    Date of Event
    March 31, 2009
    Report Date
    March 31, 2009
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    PMA / PMN Number
    K062227
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE NURSE STATED THAT V.A.C. THERAPY DID NOT CAUSE OR CONTRIBUTE TO THE BLEEDING EVENT, AS BLEEDING HAD ALREADY BEGAN UPON REMOVAL OF THE GAUZE DRESSING. THE NURSE ALSO STATED THAT SHE WAS TRAINED IN THE USE OF V.A.C. THERAPY. V.A.C. LABELING STATES UNDER "WOUND PREPARATION", "ENSURE ADEQUATE HEMOSTASIS HAS BEEN ACHIEVED." V.A.C. LABELING ALSO STATES, "PATIENTS WITHOUT ADEQUATE WOUND HEMOSTASIS HAVE AN INCREASED RISK OF BLEEDING, WHICH, IF UNCONTROLLED, COULD BE POTENTIALLY FATAL. THESE PATIENTS SHOULD BE TREATED AND MONITORED IN A CARE SETTING DEEMED APPROPRIATE BY THE TREATING PHYSICIAN," AND, "CONSIDERATION SHOULD BE GIVEN TO THE NEGATIVE PRESSURE SETTING AND THERAPY MODE USED WHEN INITIATING THERAPY." V.A.C. LABELING WARNS, "IF SIGNIFICANT BLEEDING DEVELOPS, IMMEDIATELY DISCONTINUE THE USE OF THE V.A.C. THERAPY SYSTEM, TAKE MEASURES TO STOP THE BLEEDING, AND DO NOT REMOVE THE FOAM DRESSING UNTIL THE TREATING PHYSICIAN OR SURGEON IS CONSULTED. DO NOT RESUME THE USE OF THE V.A.C. THERAPY SYSTEM UNTIL ADEQUATE HEMOSTASIS HAS BEEN ACHIEVED, AND THE PATIENT IS NOT AT RISK FOR CONTINUED BLEEDING." THIS COMPLAINT IS BEING REPORTED AS USE ERROR, V.A.C. THERAPY WAS APPLIED TO AN ACTIVELY BLEEDING WOUND, WHICH MAY HAVE CONTRIBUTED TO THE PATIENT REQUIRING THREE UNITS OF PACKED RED BLOOD CELLS.

    Description of Event or Problem · 1

    A PATIENT UNDERWENT A FEMORAL-POPLITEAL REVASCULARIZATION SURGERY AND V.A.C. THERAPY WAS INITIATED ON THE RESULTING GROIN WOUND IN 2009, IN THE ACUTE CARE FACILITY. THERE WERE NO COMPLICATIONS WITH V.A.C. THERAPY IN THE ACUTE CARE SETTING. V.A.C. THERAPY WAS DISCONTINUED ELEVEN DAYS LATER, AND A GAUZE DRESSING WAS APPLIED AS THE PATIENT WAS DISCHARGED TO A LONG TERM CARE FACILITY. UPON ADMISSION TO THE LONG TERM CARE FACILITY, THE NURSE (RN) STATED THAT UPON REMOVAL OF THE GAUZE DRESSING A VESSEL WAS RUPTURED AND BEGAN BLEEDING. THE NURSE STATED THAT SHE APPLIED A V.A.C. DRESSING TO THE WOUND WITH ACTIVE BLEEDING, WHICH RESULTED IN DIFFICULTY OBTAINING A SEAL. THE NURSE INDICATED THAT ONCE A SEAL WAS OBTAINED, V.A.C. THERAPY WAS APPLIED AND SUBSEQUENTLY TWO CANISTERS WERE FILLED WITH BRIGHT RED BLOOD. THE NURSE STATED SHE STOPPED THERAPY REMOVED THE DRESSING AND CALLED KCI AT WHICH TIME SHE WAS DIRECTED TO APPLY PRESSURE, CONTACT THE PATIENT'S PHYSICIAN AND GET PATIENT TO NEAREST EMERGENCY ROOM. IN THE EMERGENCY ROOM, BLEEDING WAS STOPPED BY REPAIR OF THE VESSEL AND THE PATIENT REQUIRED TWO UNITS OF PACKED RED BLOOD CELLS. THE NURSE STATED THAT THE PATIENT RETURNED TO THE LONG TERM CARE FACILITY THE SAME DAY AND RECEIVED ONE ADDITIONAL UNIT OF PACKED RED BLOOD CELLS. THE NURSE STATED V.A.C. THERAPY WAS RESUMED THE FOLLOWING MONTH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention ASKU