BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CA 210 DIALYZER (CELLULOSE ACETATE)

    MDR report key: 265087 · Received February 21, 2000

    Report

    Report Number
    1423500-2000-00242
    Event Type
    Malfunction
    Date Received
    February 21, 2000
    Date of Event
    November 9, 1999
    Report Date
    January 24, 2000
    Manufacturer
    NISSHO
    Product Code
    FJI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HEALTH CARE PROFESSIONAL REPORTS 3 FIBER LEAKS NOTED BY BLOOD IN THE DIALYSATE COMPARTMENT DURING THE ONSET OF THE PT TREATMENT. THESE EVENTS OCCURRED ON 11/09/1999, 11/19/1999 AND 11/29/1999. NEW DISPOSABLES USED TO CONTINUE THE TREATMENTS WITHOUT INCIDENT. ESTIMATED BLOOD LOSS = 150CC. THE DIALYZERS WERE REUSED 2, 17 AND 18 TIMES PRIOR TO THE REPORTED EVENT. HCP REPORTS NO PT INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CA 210 DIALYZER (CELLULOSE ACETATE) HOLLOW FIBER DIALYZER FJI NISSHO CA 210 A99D12

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN RENATRON.