BEUDAMED
    FDA Adverse Event Death Summary report: N

    V.A.C. THERAPY SYSTEM

    MDR report key: 2474134 · Received February 28, 2012

    Report

    Report Number
    1625774-2012-00013
    Event Type
    Death
    Date Received
    February 28, 2012
    Date of Event
    January 29, 2012
    Report Date
    January 30, 2012
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2012, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY KCI FIELD SERVICE, AND THE UNIT PASSED THE QUALITY CONTROL CHECKS AND MET SPECIFICATIONS. ON (B)(6) 2012, THE DEVICE WAS PLACED WITH THE PT. ON (B)(6) 2012, THE DEVICE WAS RETURNED TO KCI FOR EVAL. 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 W/O USING V.A.C. THERAPY, CERTAIN PTS ARE AT HIGH RISK OF BLEEDING COMPLICATIONS. THE FOLLOWING TYPES OF PTS ARE AT INCREASED RISK OF BLEEDING, WHICH, IF UNCONTROLLED, COULD BE POTENTIALLY FATAL. PTS 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 ANASTOMOSES OR GRAFTS) /ORGAN, INFECTION, TRAUMA, RADIATION, PTS W/O ADEQUATE WOUND HEMOSTASIS, PT'S WHO HAVE BEEN ADMINISTERED ANTICOAGULANTS OR PLATELET AGGREGATION INHIBITORS, PTS WHO DO NOT HAVE ADEQUATE TISSUE COVERAGE OVER VASCULAR STRUCTURES. IF V.A.C. THERAPY IS PRESCRIBED FOR PTS 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. IF DRESSING ADHERES TO WOUND, CONSIDER INTRODUCING STERILE WATER OR NORMAL SALINE INTO THE DRESSING, WAITING 15-30 MINS, 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. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: 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 PT SHOULD BE CLOSELY MONITORED FOR BLEEDING IN A CARE SETTING DEEMED APPROPRIATE BY THE TREATING PHYSICIAN.

    Description of Event or Problem · 1

    THE FOLLOWING INFO WAS REPORTED TO KCI BY THE HOME HEALTH NURSE: ON (B)(6) 2012, V.A.C. THERAPY WAS INITIATED. ON (B)(6) 2012 AROUND 7:30PM, IT WAS CLAIMED THAT THE PT HAD VOMITED BLOOD AND HAD STARTED TO BLEED FROM THE WOUND SITE AND WENT TO THE EMERGENCY ROOM. THE PT HAD ARRIVED AT THE HOSPITAL AND HAD A CARDIAC ARREST. CPR WAS INITIATED, RHYTHM WAS OBTAINED. THE PT WAS THEN STABILIZED AND TRANSFERRED VIA LIFE FLIGHT TO ANOTHER HOSPITAL. WHEN THE PT ARRIVED TO THE SECOND HOSPITAL, THE PT WAS TAKEN TO THE OPERATING ROOM FOR EVAL. DURING SURGERY AND UPON REMOVAL OF V.A.C. DRESSING, IT WAS IDENTIFIED THAT ON THE VENTRAL PORTION OF THE FOREARM THERE WAS ARTERIAL BLOOD COMING FROM TWO POINTS ON THE RADIAL ARTERY. THE RADIAL ARTERY WAS REPAIRED. ON (B)(6) 2012, IT WAS REPORTED THAT THE PT HAD EXPIRED AT 4:00PM. ACCORDING TO THE REPORT, A NON-ADHERENT LAYER WAS NOT USED TO PROTECT UNDERLYING VESSELS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death CARDIZEM| ASPIRIN