BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROSORBA COLUMN

    MDR report key: 271950 · Received March 29, 2000

    Report

    Report Number
    3023288-2000-00005
    Event Type
    Death
    Date Received
    March 29, 2000
    Date of Event
    February 24, 2000
    Report Date
    March 28, 2000
    Manufacturer
    CYPRESS BIOSCIENCE, INC.
    Product Code
    LQQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A PT WITH RHEUMATOID ARTHRITIS RECEIVED 9 PROSORBA COLUMN TREATMENTS WITHOUT PROBLEMS. A CENTRAL VENOUS CATHETER HAD BEEN PLACED BEFORE COMMENCEMENT OF PROSORBA TREATMENTS. THE 10TH TREATMENT WAS ABORTED DUE TO OBSERVED HEMOLYSIS. APHERESIS UNIT REPORTED THAT NO HEMOLYSED BLOOD WAS RETURNED TO THE PT AND A COOMBS TEST PERFORMED WITHIN 24 HOURS WAS NEGATIVE FOR HEMOLYSIS. TREATMENT 11 WAS UNEVENTFUL. PT BECAME ILL THREE DAYS AFTER 11TH TREATMENT AND WAS HOSPITALIZED 2 DAYS LATER. PT PRESENTED WITH SYMTPOMS OF DIFFUSE INTRAVASCULAR COAGULATION (ELEVATED FIBRIN SPLIT PRODUCTS, DECREASED FIBRINOGEN, THROMBOCYTOPENIA). PT ALSO HAD ELEVATED TROPONIN VALUES, SUGGESTING MYOCARDIAL INJURY, LIKELY DUE TO THE ACUTE EFFECTS OF SEPSIS WITH HISTORY OF UNDERLYING ARTERIO-SCLEROTIC HEART DISEASE AND HYPERTENSION. BLOOD CULTURES TAKEN DURING HOSPITALIZATION WERE POSITIVE FOR STAPHYLOCOCCUS AUREUS. PT EXPERIENCED RENAL AND RESPIRATORY FAILURE AND SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSORBA COLUMN PROTEIN A IMMUNOADSORPTION COLUMN LQQ CYPRESS BIOSCIENCE, INC. NA 081899M

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death| H 5. NITROPATCH, 6. MIACIN SPRAY.| 1. PREDNISONE, 2. CARAFATE, 3. DIAZIDE, 4. VIOXX,