BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CT GAMMA DIALYZER (CT 190G)

    MDR report key: 298661 · Received September 28, 2000

    Report

    Report Number
    1423500-2000-00993
    Event Type
    Malfunction
    Date Received
    September 28, 2000
    Date of Event
    May 18, 2000
    Report Date
    July 9, 2000
    Manufacturer
    NISSHO CORP
    Product Code
    FJI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS 1 FIBER LEAK OCCURRED AT THE ONSET OF TREATMENT ON REUSE NUMBER 17. NOTED BY BLOOD LEAK ALARM AND CONFIRMED WITH HEMASTIX. TREATMENT WAS CONTINUED WITH NEW DIALYZER AND BLOODLINES WITHOUT INCIDENT. ESTIMATED BLOOD LOSS WAS 150CC. NO PT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CT GAMMA DIALYZER (CT 190G) HOLLOW FIBER DIALYZER FJI NISSHO CORP CT 190G A99L27X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN