BEUDAMED
    FDA Adverse Event Death Summary report: N

    V.A.C. THERAPY SYSTEM

    MDR report key: 2202623 · Received August 4, 2011

    Report

    Report Number
    1625774-2011-00097
    Event Type
    Death
    Date Received
    August 4, 2011
    Date of Event
    June 1, 2009
    Report Date
    July 6, 2011
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: WITH OR WITHOUT USING V.A.C. THERAPY, CERTAIN PATIENTS ARE AT HIGH RISK OF BLEEDING COMPLICATIONS. THE FOLLOWING TYPES OF PATIENTS ARE AT INCREASED RISK OF BLEEDING, WHICH, IF UNCONTROLLED, COULD BE POTENTIALLY FATAL. PATIENTS WHO HAVE WEAKENED OR FRIABLE BLOOD VESSELS OR ORGANS IN OR AROUND THE WOUND AS A RESULT OF, BUT NOT LIMITED TO: SUTURING OF THE BLOOD VESSEL (NATIVE ANASTAMOSES OR GRAFTS )/ORGAN, INFECTION, TRAUMA, RADIATION PATIENTS WITHOUT ADEQUATE WOUND HEMOSTASIS, PATIENTS WHO HAVE BEEN ADMINISTERED ANTICOAGULANTS OR PLATELET AGGREGATION INHIBITORS, PATIENTS WHO DO NOT HAVE ADEQUATE TISSUE COVERAGE OVER VASCULAR STRUCTURES. IF V.A.C. THERAPY IS PRESCRIBED FOR PATIENTS WHO HAVE AN INCREASED RISK OF BLEEDING COMPLICATIONS, THEY SHOULD BE TREATED AND MONITORED IN A CARE SETTING DEEMED APPROPRIATE BY THE TREATING PHYSICIAN. IF ACTIVE BLEEDING DEVELOPS SUDDENLY OR IN LARGE AMOUNTS DURING V.A.C. THERAPY, OR IF (B)(4) (BRIGHT RED) BLOOD IS SEEN IN THE TUBING OR IN THE CANISTER, IMMEDIATELY STOP V.A.C. THERAPY, LEAVE DRESSING IN PLACE, TAKE MEASURES TO STOP THE BLEEDING, AND SEEK IMMEDIATE MEDICAL ASSISTANCE. THE V.A.C. THERAPY UNITS AND DRESSINGS SHOULD NOT BE USED TO PREVENT, MINIMIZE OR STOP VASCULAR BLEEDING. IF DRESSING ADHERES TO WOUND, CONSIDER INTRODUCING STERILE WATER OR NORMAL SALINE INTO THE DRESSING, WAITING 15-30 MINUTES, THEN GENTLY REMOVING THE DRESSING FROM THE WOUND. CONSIDER PLACING A SINGLE LAYER, WIDE-MESHED, NON-ADHERENT MATERIAL PRIOR TO PLACEMENT OF THE V.A.C. FOAM DRESSING. ALWAYS ENSURE THAT V.A.C. FOAM DRESSINGS DO NOT COME IN DIRECT CONTACT WITH VESSELS OR ORGANS. USE OF A THICK LAYER OF NATURAL TISSUE SHOULD PROVIDE THE MOST EFFECTIVE PROTECTION. IF A THICK LAYER OF NATURAL TISSUE IS NOT AVAILABLE OR IS NOT SURGICALLY POSSIBLE, MULTIPLE LAYERS OF FINE-MESHED, NON-ADHERENT MATERIAL, OR BIOENGINEERED TISSUE MAY BE CONSIDERED AS AN ALTERNATIVE, IF DEEMED BY THE TREATING PHYSICIAN TO PROVIDE A COMPLETE PROTECTIVE BARRIER. IF USING NON-ADHERENT MATERIALS, ENSURE THAT THEY ARE SECURED IN A MANNER AS TO MAINTAIN THEIR PROTECTIVE POSITION THROUGHOUT THERAPY. CONSIDERATION SHOULD ALSO BE GIVEN TO THE NEGATIVE PRESSURE SETTING AND THERAPY MODE USED WHEN INITIATING THERAPY. CAUTION SHOULD BE TAKEN WHEN TREATING LARGE WOUNDS THAT MAY CONTAIN HIDDEN VESSELS, WHICH MAY NOT BE READILY APPARENT. THE PATIENT SHOULD BE CLOSELY MONITORED FOR BLEEDING IN A CARE SETTING DEEMED APPROPRIATE BY THE TREATING PHYSICIAN.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED TO KCI FROM A LITERATURE CASE STUDY: IN A CASE STUDY TITLED VACUUM ASSISTED CLOSURE (V.A.C.) THERAPY FOR VASCULAR GRAFT INFECTION (B)(6) IN THE GROIN - A TEN-YEAR MULTICENTER EXPERIENCE. IT WAS REPORTED THAT THERE WAS ALLEGED DEATH DUE TO SECONDARY BLEEDING IN A PATIENT. PRIOR TO V.A.C. THERAPY, THE PATIENT HAD A (B)(6) COLONIZED IN THE WOUND. THE GRAFT WAS CLEANED AND VESSELS ISOLATED, COMMON FEMORAL ARTERY AND COMMON FEMORAL VEIN AND WOUND DEBRIDEMENT DONE WITH SANTONIOUS FLAP. IT WAS SPECULATED BY THE AUTHORS THAT THE EVENT WAS A RESULT OF SECONDARY MASSIVE BLOOD LOSS AFTER A RUPTURED VESSEL DUE TO INFECTIVE EROSION OF THE NATIVE VESSEL AND MYOCARDIAL INFARCTION. V.A.C. THERAPY WAS IN PLACE FOR TWO WEEKS PRIOR TO THE EVENT. THE LAST DRESSING CHANGE WAS THREE DAYS PRIOR TO THE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death GENTAMICIN 80 MG INTRAVENOUS EVERYDAY| LAEROFLOXACIN 500MG INTRAVENOUS EVERY DAY