BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMMUNOSORBA COLUMN

    MDR report key: 396469 · Received May 24, 2002

    Report

    Report Number
    3033270-2002-00002
    Event Type
    Death
    Date Received
    May 24, 2002
    Date of Event
    April 1, 2002
    Report Date
    May 24, 2002
    Manufacturer
    FRESENIUS HEMOCARE, INC.
    Product Code
    LQQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH GUILLAIN BARRE SYNDROME AND LUNG INFECTION DEVELOPED SEPSIS AND DIC THE EVENING AFTER THEIR THIRD IMMUNOSORBA TREATMENT. SYMPTOMS PROGRESSED TO MULTIPLE ORGAN FAILURE/SHOCK AND THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMUNOSORBA COLUMN IMMUNOSORBA COLUMN LQQ FRESENIUS HEMOCARE, INC. 9797200 01-046

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death CLAFORAN, REFOBACIN.| TAVOR, ESIDRIX, BEPANTHEN, PROSTIGMIN, TAVANIC,| VANCOMYCIN, KALIUM-MALAT, HYDROCORTISONE, DOPAMINE