BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CT GAMMA DIALYZER (CT 190G)

    MDR report key: 410627 · Received August 8, 2002

    Report

    Report Number
    1423500-2002-00928
    Event Type
    Malfunction
    Date Received
    August 8, 2002
    Date of Event
    July 23, 2002
    Report Date
    July 24, 2002
    Manufacturer
    NIPRO CORPORATION
    Product Code
    FJI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CLINICAL MANAGER (CM) REPORTS 4 INCIDENTS OF BLOOD LEAKS WITH CT 190G DIALYZERS. THEY WERE ALL ON THEIR 6TH USE. THE CLINIC HAS ONLY BEEN OPEN SINCE THE BEGINNING OF THIS MONTH. THE TREATMENTS WERE RESTARTED WITH NEW DISPOSABLES. THE ESTIMATED BLOOD LOSS IS 150CC PER PATIENT. CM REPORTS THAT THERE ARE NO PATIENT INJURIES OR MEDICAL INTERVENTIONS ASSOCIATED WITH THESE INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CT GAMMA DIALYZER (CT 190G) HOLLOW FIBER DIALYZER FJI NIPRO CORPORATION CT 190G A01L10X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN MERIDIAN HEMODIALYSIS MACHINE.