BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMMUNOSORBA

    MDR report key: 390602 · Received April 26, 2002

    Report

    Report Number
    3033270-2002-00001
    Event Type
    Death
    Date Received
    April 26, 2002
    Date of Event
    April 12, 2002
    Report Date
    April 26, 2002
    Manufacturer
    FRESENIUS HEMOCARE, INC.
    Product Code
    LQQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT BEING TREATED FOR FACTOR VIII INHIBITOR REC'D THEIR FIRST TREATMENT. PRIOR TO THE TREATMENT NURSES STATED THEIR KIDNEYS WERE FAILING, NO URINARY OUTPUT DESPITE LASIX ADMINISTRATION. THEIR RESPIRATIONS WERE VERY LABORED. APPROXIMATELY 1 1/2 HOURS INTO THE TREATMENT THEIR RESPIRATORY STATUS WORSENED. A CODE WAS CALLED, THE PROCEDURE WAS STOPPED AND THE PATIENT WAS TRANSFERRED TO ICU. PT EXPIRED THAT EVENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMUNOSORBA IMMUNOADSORPTION COLUMN LQQ FRESENIUS HEMOCARE, INC. * C01063 & C01064

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death