BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 160NRE DIALYZER FINISEHD ASSY

    MDR report key: 3102021 · Received May 3, 2013

    Report

    Report Number
    1713747-2013-00118
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 5, 2013
    Manufacturer
    OGDEN MANUFACTURING
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION AND THE COMPLAINT IS CONFIRMED. AND INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NONCONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A HEMODIALYSIS USER FACILITY HAS REPORTED THAT DURING TREATMENT A BLOOD LEAK OCCURRED. UPON INITIATION OF TREATMENT, THE MACHINE ALARMED AND TEST STRIPS CONFIRMED THE BLOOD LEAK. ESTIMATED BLOOD LOSS WAS 100ML'S. NO MEDICAL INTERVENTION WAS REQUIRED AND THE PATIENT HAD NO ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195386 OPTIFLUX 160NRE DIALYZER FINISEHD ASSY FJI OGDEN MANUFACTURING 13BU05009

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR FRESENIUS K MACHINE