BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY

    MDR report key: 3152581 · Received June 5, 2013

    Report

    Report Number
    3009897021-2013-00045
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    KCI USA INC.
    Product Code
    OMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2013, THE DEVICE WAS TESTED PER QUALITY CONTROL (QC) PROCEDURE BY KCI FIELD SERVICE, AND THE UNIT PASSED THE QC CHECKS AND MET SPECIFICATIONS. ON (B)(6) 2013, THE DEVICE WAS PLACED WITH THE PATIENT. ON (B)(6) 2013, THE DEVICE WAS RETURNED TO KCI FOR EVALUATION. INSPECTION AND TESTING OF THE DEVICE DID NOT REVEAL ANY EVIDENCE OF AN OPERATIONAL MALFUNCTION WITH THE UNIT. 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 VESSELS OR ORGANS IN OR AROUND THE WOUND AS A RESULT OF, BUT NOT LIMITED TO: SUTURING OF THE BLOOD VESSEL (NATIVE ANASTOMOSIS 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 FRANK (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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT: THE PATIENT ALLEGED THE CANISTER FILLED WITH BLOOD, AND WAS ADMITTED TO THE HOSPITAL FOR SURGERY, DATE NOT PROVIDED. PER THE PATIENT'S MEDICAL RECORDS, ON (B)(6) 2013, THE PHYSICIAN OBSERVED A "CAVITY FILLED WITH ORGANIZED CLOT," AND THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR EVACUATION OF A HEMATOMA THAT REQUIRED CAUTERIZATION AND TWO SUTURES. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE SAME DAY. THE PATIENT CONTINUED TO RECEIVE V.A.C. THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247875 V.A.C. THERAPY OMP KCI USA INC. ACTIV.A.C.

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization| R