BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROSORBA COLUMN

    MDR report key: 390125 · Received April 19, 2002

    Report

    Report Number
    3032792-2002-00004
    Event Type
    Death
    Date Received
    April 19, 2002
    Date of Event
    April 15, 2002
    Report Date
    April 19, 2002
    Manufacturer
    FRESENIUS HEMOCARE, INC.
    Product Code
    LQQ
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH TTP WAS ADMITTED TO THE HOSPITAL WITH FEVER, NAUSEA AND VOMITIMG THE EVENING OF THEIR FIRST PROSORBA COLUMN TREATMENT. PT RAPIDLY DEVELOPED DIC, MULTIPLE ORGAN FAILURE AND EXPIRED AT APPROXIMATELY 10:30 PM THAT SAME EVENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSORBA COLUMN IMMUNOADSORPTION COLUMN LQQ FRESENIUS HEMOCARE, INC. 9798701 MGN002J

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Death PROCARDIA, PREDNISONE, PRILOSEC.