BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROSORBA COLUMN

    MDR report key: 570891 · Received February 3, 2005

    Report

    Report Number
    3032792-2005-00004
    Event Type
    Death
    Date Received
    February 3, 2005
    Date of Event
    January 5, 2005
    Manufacturer
    FRESENIUS HEMOCARE
    Product Code
    LQQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT COLLAPSED DURING EVENING AFTER FIRST PROSORBA TREATMENT. TRANSPORTED TO HOSPITAL WHERE THEY EXPIRED. THEY HAD HISTORY OF THROMBOTIC EVENTS AND WAS NOT TAKING ASPIRIN. PATIENT HAD A PLT COUNT OF 458 PRIOR TO TREATMENT. NO AUTOPSY WAS DONE AND NO DIAGNOSIS RECEIVED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSORBA COLUMN PROSORBA COLUMN LQQ FRESENIUS HEMOCARE 9798701 QHN001C

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death VICODAN, LODINE, ALBUTEROL