BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROSORBA COLUMN

    MDR report key: 598176 · Received April 29, 2005

    Report

    Report Number
    3032792-2005-00008
    Event Type
    Death
    Date Received
    April 29, 2005
    Date of Event
    March 24, 2005
    Report Date
    April 28, 2005
    Manufacturer
    FRESENIUS HEMOCARE
    Product Code
    LQQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT WHO DEVELOPED CARDIAC ARRHYTHMIAS TWO DAYS AFTER PT'S SECOND TREATMENT AND ALSO A "RIGHT CEREBRAL ISCHEMIC INSULT" (PARESIS LEFT ARM). DESPITE THIS PT UNDERWENT A THIRD TREATMENT 2 WEEKS LATER. LATE THAT EVENING PT HAD ANOTHER STROKE-LIKE EPISODE. PT EXPIRED 2 DAYS LATER, NO AUTOPSY DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSORBA COLUMN PROSORBA COLUMN LQQ FRESENIUS HEMOCARE 9798701 QKN002B

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death OMEPRAZOL, TRAMADOL, PREDNISONE, ORIRIL, ASPIRIN.