BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPTIFLUX 160NR DIALYZER FINISHED ASSMBLY

    MDR report key: 464184 · Received January 30, 2003

    Report

    Report Number
    1713747-2002-00057
    Event Type
    Other
    Date Received
    January 30, 2003
    Date of Event
    October 14, 2002
    Manufacturer
    OGDEN MANUFACTURING
    Product Code
    FJI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FACILITY REPORTS OF AN INTERNAL BLOOD LEAK AT THE INITIATION OF TREATMENT. BLOOD WAS NOTED IN THE OUTFLOW DIALYSATE HOSE WHILE INITIATING TREATMENT. BLOOD CULTURED, DIALYSATE CULTURED AND CBC SENT TO SPECTRA PER STANDING ORDERS. DR. CONTACTED. PATIENT WAS GIVEN 1 GM ANCEF AT THE END OF TREATMENT. PATIENT WAS AFEBRILE AND DISCHARGED HOME IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIFLUX 160NR DIALYZER FINISHED ASSMBLY HEMODIALYZER FJI OGDEN MANUFACTURING NA 2HU327

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention