BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABTHERA ABDOMINAL THERAPY SYSTEM

    MDR report key: 1924847 · Received December 9, 2010

    Report

    Report Number
    1625774-2010-00108
    Event Type
    Injury
    Date Received
    December 9, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 9, 2010
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    PMA / PMN Number
    K083357
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE DEVICE WAS NOT RETURNED, NO DEVICE EVAL PERFORMED.

    Description of Event or Problem · 1

    THE PT WAS IN A MOTORCYCLE CRASH. THE PT WAS INITIALLY TAKEN TO THE OPERATING ROOM FOR DAMAGE CONTROL LAPAROTOMY AND FOUND TO HAVE A GRADE V LIVER LACERATION. THE PT EXPERIENCED MASSIVE BLOOD LOSS AND REQUIRED SIGNIFICANT RESUSCITATION AND INTRA-ABDOMINAL PACKING INTRAOPERATIVELY. THE PT HAD ABTHERA DRESSING PLACED AS A TEMPORARY ABDOMINAL CLOSURE AND WAS TAKEN BACK TO THE INTENSIVE CARE UNIT FOR WARMING AND AGGRESSIVE RESUSCITATION. THE PT WAS HEMODYNAMICALLY UNSTABLE SECONDARY TO MASSIVE HEMORRHAGE AND REQUIRED SIGNIFICANT ONGOING ADMINISTRATION OF BLOOD PRODUCTS. THE PT HAD CONTINUED INTRA-ABDOMINAL BLEEDING AND SUBSEQUENTLY DEVELOPED INTRA-ABDOMINAL HYPERTENSION AND ABDOMINAL COMPARTMENT SYNDROME. THE SURGICAL TEAM TOOK THE PT BACK TO THE OPERATING ROOM WHERE ABTHERA DRESSING WAS REMOVED. THE PT WAS FOUND TO HAVE SPLENIC BLEEDING WITH APPROX TWO LITERS OF BLOOD IN PERITONEAL CAVITY. A LARGE BLOOD CLOT WAS NOTED TO BE PRESENT UNDERNEATH THE ABTHERA DRESSING, EVACUATION OF BLOOD AND HEMATOMA FROM THE ABDOMEN, AND SURGICAL CORRECTION OF THE TRAUMATIC BLEEDING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LEVOPHED| DILANTIN 100MG/2ML/IV| MAGNESIUM SULFATE IVPB| CEFAZOLIN 2 GM/NS 100ML IVPB| MAGNESIUM SULFATE IVPB| CALCIUM GLUCONATE 2,000MG IV ONCE| TYLENOL 650 MG SUPPOSITORY