BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAMBRO LUNDIA, ALPHA 500 PLATE DIALYZER

    MDR report key: 27573 · Received October 31, 1995

    Report

    Report Number
    MW1007516
    Event Type
    Malfunction
    Date Received
    October 31, 1995
    Date of Event
    July 31, 1995
    Report Date
    October 4, 1995
    Manufacturer
    COBE RENAL CARE, INC.
    Product Code
    FJG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BETWEEN 7/31/95 AND 9/1/95, 7 PTS INCURRED BLOOD LOSSES OF APPROX 125 CC EACH WHEN BLOOD LEAKS OCCURRED ON THE PLATE DIALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMBRO LUNDIA, ALPHA 500 PLATE DIALYZER PLATE DIALYER FJG COBE RENAL CARE, INC. 5-0510-N 50512N11

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other