BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CT GAMMA DIALYZER (9CT 190G)

    MDR report key: 189584 · Received September 25, 1998

    Report

    Report Number
    1423500-1998-01753
    Event Type
    Malfunction
    Date Received
    September 25, 1998
    Date of Event
    September 1, 1998
    Report Date
    September 18, 1998
    Manufacturer
    NISSHO
    Product Code
    FJI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HEALTH CARE PROFESSIONAL REPORTS ONE BLOOD LEAK NOTED INTO THE DIALYSATE COMPARTMENT DURING PT TREATMENT. THE DIALYZER AND LINES WERE REPLACED AND THE TREATMENT WAS CONTINUED WITHOUT INCIDENT. ESTIMATED BLOOD LOSS "+150CC." DIALYZER WAS REUSED 20 TIMES. NO REPORTS OF FIBER LEAK OCCURRED WITH INITIAL 19 USES OF DIALYZERS. HEALTH CARE PROFESSIONAL REPORTS NO PT INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CT GAMMA DIALYZER (9CT 190G) HOLLOW FIBER DIALYZER FJI NISSHO CT190G A98D01X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN RENATRON II