BEUDAMED
    FDA Adverse Event Death Summary report: N

    BARIMAXX II

    MDR report key: 859321 · Received May 24, 2007

    Report

    Report Number
    1625774-2007-00017
    Event Type
    Death
    Date Received
    May 24, 2007
    Date of Event
    April 20, 2007
    Report Date
    April 24, 2007
    Manufacturer
    KCI USA, INC.
    Product Code
    FNL
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT WAS VERY ILL AND IN AN ACUTE CARE SETTING FOLLOWING A LIVER TRANSPLANT. IN 2007, A NURSE PUT THE BOTTOM SIDE RAIL DOWN BY THE PT'S LEGS TO PERFORM WOUND CARE. AFTER COMPLETING THE WOUND CARE, THE NURSE TURNED THE ROTATION ON AND LEFT THE PT'S ROOM TO GET THE PT'S MEDICATIONS. WHEN THE NURSE RETURNED TO THE PT'S ROOM, THE PT HAD SLID ONTO THE FLOOR FROM THE BED; THE SIDE RAIL WAS DOWN AND THE ATTACHED SIDE RAIL PADDING WAS DISLODGED AND UNATTACHED FROM THE SIDE RAIL. THE PT'S TRACHEOSTOMY WAS INTACT AND THE PT'S NEUROLOGICAL STATUS REMAINED UNCHAGED. THE PT REPORTEDLY EXPIRED FROM INTERNAL INJURIES AND BLEEDING FOUR DAYS LATER. PERSONNEL FROM KCI, THE HOSP AND ECRI EXAMINED THE BED AND FOUND THAT BOTH PRODUCTS (BARIMAXX II AND MAXXAIR ETS) WERE FUNCTIONING AS DESIGNED. MAXXAIR ETS LABELING STATES AS A "CAUTION": "PRIOR TO ENGAGING THE TURN FEATURE, ENSURE THAT BED FRAME HAS SIDE RAILS AND THAT ALL SIDE RAILS ARE FULLY ENGAGED IN THEIR FULL UPRIGHT AND LOCKED POSITION." ALTHOUGH IT WAS CONCLUDED THAT BOTH PRODUCTS (BARIMAXX II AND MAXXAIR ETS) WERE FUNCTIONING AS DESIGNED STATES: "WITHOUT REGARD TO WHETHER THE KCI PRODUCT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY, ANY DEATH OR SERIOUS INJURY ASSOCIATED WITH PARTIAL OR COMPLETE EXIT FROM A KCI SURFACE OR BED WILL BE REPORTED".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WHO HAD UNDERGONE A LIVER TRANSPLANT AND WAS ON A BARIMAXX II AND MAXXAIR ETS FELL OUT OF BED AS THE MAXXAIR ETS WAS ROTATING AND THE SIDE RAILS WERE DOWN. THE PT REPORTEDLY EXPIRED FROM INTERNAL INJURIES AND BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARIMAXX II FNL FNL KCI USA, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Death MAXXAIR ETS MRS (THERAPEUTIC, EXPANDABLE TURNING| SURFACE FOR THE BARIMAXX FAMILY OF BEDS)