BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSORBA COLUMN

    MDR report key: 285088 · Received May 26, 2000

    Report

    Report Number
    3023288-2000-00006
    Event Type
    Injury
    Date Received
    May 26, 2000
    Date of Event
    April 27, 2000
    Report Date
    May 26, 2000
    Manufacturer
    CYPRESS BIOSCIENCE, INC.
    Product Code
    LQQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT WITH RHEUMATOID ARTHRITIS COMPLETED 11 PROSORBA TREATMENTS WITHOUT INCIDENT. DURING 12TH TREATMENT, PT NOTICED BLURRING IN LEFT EYE, WHICH PT DID NOT REPORT. PT'S VISION CONTINUED TO DETERIORATE AND PT WAS ADMITTED TO THE HOSP LATER THE SAME DAY. A DIAGNOSIS OF RETINAL VASCULAR OCCLUSION WAS MADE. PT WAS STARTED ON ANTI-COAGULATION AND STABILIZED ON COUMADIN. IT WAS REPORTED THAT THE COLUMN WAS NOT PRIMED WITH HEPARIN DUE TO HISTORY OF HEPARIN INDUCED THROMBOCYTOPENIA. THE METHOD TO PRIME THE COLUMN IS UNKNOWN. IT WAS ALSO REPORTED THAT THE PT IS NOW FOUND TO BE POSITIVE FOR ANTICARDIOLIPIN ANTIBODY AND HAD NO PREVIOUS HISTORY OF THROMBOEMBOLIC PHENOMENON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSORBA COLUMN PROTEIN A IMMUNOADSORPTION COLUMN LQQ CYPRESS BIOSCIENCE, INC. NA 102199B

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| S 1. CYTOTEC, 2. FOSAMAX, 3. DITROPAN.