BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROSORBA COLUMN

    MDR report key: 282419 · Received June 14, 2000

    Report

    Report Number
    3023288-2000-00007
    Event Type
    Death
    Date Received
    June 14, 2000
    Date of Event
    April 28, 2000
    Report Date
    June 14, 2000
    Manufacturer
    CYPRESS BIOSCIENCE, INC.
    Product Code
    LQQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PT RECEIVED 8 PROSORBA COLUMN TREATMENTS. JUST PRIOR TO, AND CONCURRENT WITH, PROSORBA TREATMENTS, THE PT WAS STARTED ON CYTOXAN THERAPY TO TREAT PROGRESSIVE AND AGGRESSIVE MONONEURITIS MULTIPLEX AND RA. THE PT DEVELOPED APLASTIC ANEMIA AND THROMBOCYTOPENIA WHICH, IN THE PHYSICIAN'S OPINION, WAS THE RESULT OF THE CYTOXAN THERAPY AND/OR THE UNDERLYING AUTOIMMUNE DISEASE. SUBSEQUENT TO THE EIGHTH PROSORBA COLUMN TREATMENT, THE PT WAS HOSPITALIZED WITH PROFOUND WEAKNESS. PT WAS FOUND TO BE SEVERELY PANCYTOPENIC AND A BONE MARROW BIOPSY WAS CONSISTENT WITH APLASTIC ANEMIA. THE PT WAS TRANSFUSED AND TREATED WITH IV ANTIBIOTICS. THE PT CONTINUED TO WEAKEN AND EXPIRED APPROX TWO WEEKS LATER, REPORTEDLY FROM COMPLICATIONS OF PANCYTOPENIA AND INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSORBA COLUMN PROTEIN A IMMUNOADSORPTION COLUMN LQQ CYPRESS BIOSCIENCE, INC. NA 082599F

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death NEUPOGEN, CYTOXAN, PREMPRO.