BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROSORBA COLUMN

    MDR report key: 44569 · Received October 25, 1996

    Report

    Report Number
    3023288-1996-00005
    Event Type
    Death
    Date Received
    October 25, 1996
    Date of Event
    September 21, 1996
    Report Date
    September 25, 1996
    Manufacturer
    CYPRESS BIOSCIENCE, INC. (FORMERLY IMRE CORP.)
    Product Code
    LQQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE 25 YR OLD MALE PT WITH ITP RECEIVED HIS 5TH TREATMENT OF 2000 ML PLASMA ON 9/20/96. THE PROCEDURE WAS FINISHED AT 3:00 PM. THE PT DEVELOPED LEFT SIDE HEMIPARESIS AROUND 8:00 PM. THE PT WAS ADMITTED TO INTENSIVE CARE UNIT (ICU), AND WAS DIAGNOSED CLINICALLY AS A DEEP THALMIC BLEED AND DECLARED DNR (DO NOT RESUSCITATE) AT 2:00 AM ON 9/21/96. PLATELET COUNTS HAD RANGED FROM 2000-3000 OVER THE COURSE OF THE FIVE TREATMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSORBA COLUMN PROTEIN A IMMUNOADSORPTION COLUMN LQQ CYPRESS BIOSCIENCE, INC. (FORMERLY IMRE CORP.) NA 100295E

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Death