BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CT GAMMA DIALYZER (CT 190G)

    MDR report key: 381111 · Received February 27, 2002

    Report

    Report Number
    1423500-2002-00264
    Event Type
    Malfunction
    Date Received
    February 27, 2002
    Date of Event
    November 18, 2001
    Report Date
    January 28, 2002
    Manufacturer
    NISSHO CORP.
    Product Code
    FJI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS ONE INCIDENT OF A BLOOD LEAK AT THE ONSET OF TREATMENT ON USE NUMBER 4. NOTED BY A BLOOD LEAK ALARM AND CONFIRMED WITH HEMASTIX. TREATMENT WAS CONTINUED WITH A DIALYZER AND NEW BLOODLINES WITHOUT FURTHER INCIDENT. NO PT INJURY OR MEDICAL INTERVENTION WAS 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 E01F11X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN