BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY SYSTEM

    MDR report key: 1000073 · Received February 18, 2008

    Report

    Report Number
    1625774-2008-00005
    Event Type
    Injury
    Date Received
    February 18, 2008
    Report Date
    January 18, 2008
    Manufacturer
    KCI USA, INC.
    Product Code
    JCX
    PMA / PMN Number
    K063692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    V.A.C. LABELING STATES UNDER "WARNING": "ALL EXPOSED OR SUPERFICIAL VESSELS AND ORGANS IN OR AROUND THE WOUND MUST BE COMPLETELY COVERED AND PROTECTED PRIOR TO THE ADMINISTRATION OF V.A.C. THERAPY." IT 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. CAUTION SHOULD BE USED IN TREATING PATIENTS ON DOSES OF ANTICOAGULANTS OR PLATELET AGGREGATION INHIBITORS THOUGHT TO INCREASE THEIR RISK FOR BLEEDING (RELATIVE TO THE TYPE AND COMPLEXITY OF THE WOUND). CONSIDERATION SHOULD BE GIVE TO THE NEGATIVE PRESSURE SETTING AND THERAPY MODE USED WHEN INITIATING THERAPY." THE DEVICE WAS RETURNED TO KCI QUALITY ENGINEERING AND EVALUATED. THE DEVICE PERFORMED ACCORDING TO SPECIFICATION.

    Description of Event or Problem · 1

    A PATIENT WITH A HISTORY OF DIABETES, HYPERTENSION, HYPERCHOLESTEROLEMIA, CORONARY ARTERY DISEASE AND SMOKING HAD UNDERGONE AN AMPUTATION OF THE RIGHT GREAT TOE AND WAS RECEIVING V.A.C. THERAPY ON THE RESULTING WOUND. THE PATIENT WAS ALSO TAKING ANTICOAGULANTS WHICH INCLUDED ASPIRIN AND PLAVIX. V.A.C. THERAPY WAS INITIATED IN 2007. DURING THE NIGHT, THE V.A.C. TRAC PAD HAD PULLED OFF THE DRESSING WHILE THE PATIENT WAS SLEEPING; THE PATIENT REPLACED THE TRAC PAD AND THE WOUND STARTED BLEEDING. THE PATIENT CALLED THE HOME HEALTH NURSE; WHEN THE HOME HEALTH NURSE ARRIVED AT THE PATIENT'S HOME, THE V.A.C. DEVICE WAS TURNED OFF. ACCORDING TO THE HOME HEALTH NURSE, THE CANISTER AND THE DRESSING WERE FULL OF BLOOD. THE PATIENT WAS SENT TO THE EMERGENCY ROOM AND WAS ADMITTED TO THE HOSPITAL FOR 24 HOURS. THE PHYSICIAN SUTURED A VESSEL THAT WAS BLEEDING NEAR THE FOURTH TOE ON THE LATERAL SIDE OF FOOT; THE PATIENT RECEIVED 2 UNITS OF BLOOD. THE PATIENT WAS SENT HOME AND V.A.C THERAPY WAS RE-INITIATED. IN 2008, THE PATIENT'S SON NOTICED BLOOD IN THE TUBING AND TOOK THE PATIENT TO THE EMERGENCY ROOM. THE EMERGENCY ROOM PHYSICIAN HELD PRESSURE TO ESTABLISH HEMOSTASIS. V.A.C. THERAPY WAS DISCONTINUED AND AN ALTERNATE DRESSING WAS PLACED. THE PATIENT WAS SENT HOME STABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| R