BEUDAMED
    FDA Adverse Event Death Summary report: N

    COBE SPECTRA

    MDR report key: 291165 · Received August 16, 2000

    Report

    Report Number
    MW1019681
    Event Type
    Death
    Date Received
    August 16, 2000
    Date of Event
    August 5, 2000
    Report Date
    August 10, 2000
    Manufacturer
    GAMBRO BCT, INC.
    Product Code
    GKT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    POST PLASMA EXCHANGE, PT EXPERIENCED DECREASED LEVEL OF CONSCIOUSNESS, INCONTINENT OF URINE AND STOOL; PHYSICIANS CONTACTED. PHYSICAL EXAM DONE. SOLUMEDROL 125 MG IV GIVEN, BREATHING TREATMENT DONE. PT DISCHARGED FROM UNIT TO PT ROOM. SEVERAL HRS LATER, AIR EMBOLUS NOTED BY CT SCAN. MACHINE CHECKED BY MFR. NO PROBLEMS FOUND. RN UNABLE TO DETERMINE WHEN OR HOW AIR GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE SPECTRA APHERESIS CELL SEPARATOR GKT GAMBRO BCT, INC. 950000000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death