BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CT GAMMA DIALYZER (CT 190G)

    MDR report key: 317855 · Received February 23, 2001

    Report

    Report Number
    1423500-2001-00143
    Event Type
    Malfunction
    Date Received
    February 23, 2001
    Date of Event
    September 2, 2000
    Report Date
    January 23, 2001
    Manufacturer
    NISSHO CORPORATION
    Product Code
    FJI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS ONE INCIDENT OF A BLOOD LEAK DURING PATIENT TREATMENT ON AN UNKNOWN USE NUMBER. NOTED BY A BLOOD LEAK ALARM AND VISIBLE BLOOD IN THE DIALYSATE HOSE. CONFIRMED WITH HEMASTIX. ESTIMATED BLOOD LOSS WAS 200 CC'S. TREATMENT WAS RESUMED WITH A NEW DIALYZER AND NEW BLOODLINES WITHOUT INCIDENT. NO PT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7303 CT GAMMA DIALYZER (CT 190G) HOLLOW FIBER DIALYZER FJI NISSHO CORPORATION CT 190G E00D06X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN