BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY

    MDR report key: 3152580 · Received June 5, 2013

    Report

    Report Number
    3009897021-2013-00047
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    May 5, 2013
    Report Date
    May 6, 2013
    Manufacturer
    KCI USA INC.
    Product Code
    OMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT EITHER THE ALLEGED HEMORRHAGING OR WOUND DETERIORATION ARE RELATED TO V.A.C. THERAPY. KCI HAS NOT BEEN ABLE TO OBTAIN SUFFICIENT INFORMATION TO ESTABLISH A ROOT CAUSE. THERE HAVE BEEN SEVERAL ATTEMPTS MADE TO GATHER ADDITIONAL INFORMATION, BUT THERE HAS BEEN NO RESPONSE. ON (B)(4) 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)(4) 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 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 NURSE INQUIRED ABOUT V.A.C. THERAPY USE ON A WOUND LOCATED ON THE SPINAL COLUMN WITH EXPOSED BONE. THE NURSE ALSO REPORTED THAT THE PATIENT WAS SENT TO THE EMERGENCY ROOM, DATE NOT PROVIDED, FOR EXPOSED BONE AND HEMORRHAGING FRANK BLOOD. THE PATIENT WAS DISCHARGED FROM THE EMERGENCY ROOM WITH PHYSICIAN ORDERS TO RE-APPLY V.A.C. THERAPY. PER THE PATIENT'S MEDICAL RECORD, ON (B)(6) 2013, THE NURSE NOTED OBSERVING EXPOSED BONE IN THE WOUND AND BRIGHT RED BLOOD IN THE CANISTER. THE PATIENT WAS SENT TO THE EMERGENCY ROOM, AND WAS DISCHARGED THE SAME DAY ON A WET-TO-DRY DRESSING REGIMEN WITH ORDERS TO RESUME V.A.C. THERAPY. NO SURGICAL INTERVENTION WAS PROVIDED. THE NURSE OPTED TO NOT RESUME V.A.C. THERAPY UNTIL FURTHER EVALUATION OF THE WOUND WAS PERFORMED. ON (B)(6) 2013, THE PATIENT WENT TO A DIFFERENT EMERGENCY ROOM AND WAS ADMITTED TO THE HOSPITAL. ON (B)(6) 2013, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH ORDERS TO CONTINUE INTRAVENOUS ANTIBIOTIC THERAPY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248964 V.A.C. THERAPY OMP KCI USA INC. ACTIV.A.C

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention