BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABTHERA ABDOMINAL THERAPY SYSTEM

    MDR report key: 1864324 · Received October 7, 2010

    Report

    Report Number
    1625774-2010-00093
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 9, 2010
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    PMA / PMN Number
    K083357
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ADAPTIVE DRESSING WAS SUCCESSFUL, ALLOWING REMOVAL OF THE WOUND FLUID WHILE PREVENTING AN INCREASE IN INTRA-ABDOMINAL PRESSURE. THE PHYSICIAN WAS ABLE TO CLOSE THE FASCIA TWO DAYS LATER, THE PT WAS THEN DISCHARGED FROM THE INTENSIVE CARE UNIT TO THE MEDICAL SURGICAL UNIT IN STABLE CONDITION. THE ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY (NPT) SYSTEM IS INDICATED FOR TEMPORARY BRIDGING OF ABDOMINAL WALL OPENINGS WHERE PRIMARY CLOSURE IS NOT POSSIBLE AND OR REPEAT ABDOMINAL ENTRIES ARE NECESSARY. THE INTENDED USE OF THIS SYSTEM IS FOR USE IN OPEN ABDOMINAL WOUNDS, WITH EXPOSED VISCERA, INCLUDING, BUT NOT LIMITED TO ABDOMINAL COMPARTMENT SYNDROME.

    Description of Event or Problem · 1

    ON 09 SEP 2010, A KCI REP REPORTED THAT A PT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2010, WITH ABDOMINAL COMPARTMENT SYNDROME THAT NECESSITATED A LAPAROTOMY TO RELIEVE THE INTRA-ABDOMINAL PRESSURES AND IMPROVE URINE OUTPUT AS WELL AS VENTILATION OF THE PT. ONCE THE LAPAROTOMY WAS DONE THE PT'S PRESSURES AND VENTILATION IMPROVED. WHEN ABTHERA WAS PLACED AND THERAPY INITIATED, ONCE AGAIN THE PT WAS DIFFICULT TO VENTILATE AND THE PT'S BLADDER PRESSURES WERE IN THE 40'S WITH LITTLE TO NO URINE OUTPUT FOR TWO DAYS. THE PHYSICIAN THEN ORDERED TO KEEP THE DRESSING ON, BUT TO JUST TURN THE ACTUAL ABTHERA THERAPY ON FOR 10 MINUTES OUT OF EACH HOUR TO REMOVE FLUID FROM THE ABDOMINAL CAVITY. AT KCI MEDICAL DEPARTMENT RECOMMENDATION, THE PHYSICIAN LEFT THE SPIDER PORTION OF THE DRESSING IN PLACE CUT THE FOOTBALL GRANUFOAM MUCH SMALLER, CUT A QUARTER SIZED HOLE IN THE DRAPE AND PLACED THE TRAC PAD SO THAT THERE WOULD BE NO LATERAL TENSION ON THE ABDOMINAL INCISION THAT MAY PREVENT THE PRESSURE FROM DECREASING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABTHERA ABDOMINAL THERAPY SYSTEM OMP KCI USA, INC. ABAR00266

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention