BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CT GAMMA DIALYZER (CT 190G)

    MDR report key: 381116 · Received February 27, 2002

    Report

    Report Number
    1423500-2002-00263
    Event Type
    Malfunction
    Date Received
    February 27, 2002
    Date of Event
    November 9, 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 FIVE INCIDENTS OF BLOOD LEAKS OCCURRING IN 2001 AT THE ONSET OF PT TREATMENTS. DIALYZER USE NUMBERS RANGED FROM USE NUMBER 29 TO 42. ALL THE LEAKS WERE NOTED BY BLOOD LEAK ALARMS AND CONFIRMED WITH HEMASTIX. TREATMENTS WERE CONTINUED WITH NEW DIALYZERS AND NEW BLOODLINES WITHOUT INCIDENT. NO PT INJURIES OR MEDICAL INTERVENTIONS WERE 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 E01A22X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN