BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CT GAMMA DIALYZER (CT 190G)

    MDR report key: 378000 · Received February 15, 2002

    Report

    Report Number
    1423500-2002-00207
    Event Type
    Malfunction
    Date Received
    February 15, 2002
    Date of Event
    December 10, 2001
    Report Date
    January 18, 2002
    Manufacturer
    NISSHO CORP.
    Product Code
    FJI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL (HCP) REPORTS ONE INCIDENT OF A BLOOD LEAK THAT OCCURRED AT THE ONSET OF TREATMENT ON REUSE #44. NOTED BY A BLOOD LEAK ALARM AND CONFIRMED BY HEMASTIX. ESTIMATED BLOOD LOSS WAS NEGLIGIBLE AS BLOOD WAS RETURNED TO THE PATIENT. TREATMENT WAS CONTINUED WITH A NEW DIALYZER AND NEW DISPOSABLES WITHOUT INCIDENT. NO PATIENT 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 E01B08X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN