BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMMUNOSORBA COLUMN

    MDR report key: 473824 · Received July 24, 2003

    Report

    Report Number
    3033270-2003-00003
    Event Type
    Death
    Date Received
    July 24, 2003
    Date of Event
    May 26, 2003
    Report Date
    July 23, 2003
    Manufacturer
    FRESENIUS HEMOCARE, INC.
    Product Code
    LQQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT WITH LUPUS DEVELOPED SEPSIS AND EXPIRED 4 DAYS FOLLOWING THEIR SECOND IMMUNOSORBA TREATMENT. THE PT'S CONDITION HAD BEEN DESCRIBED AS MULTIMORBID, SOMNOLENT, IMMOBILE WITH DCM, LEUKOCYTOSIS AND ELEVATED CRP. THEY WERE ALSO RECEIVING DIALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMUNOSORBA COLUMN IMMUNOSORBA COLUMN LQQ FRESENIUS HEMOCARE, INC. 9797200 PAL010A

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Death CYCLOPHOSPHAMIDE,| IVIG,| METHYLPREDNISONE,| NO FURTHER INFO.