BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 160NRE DIALYZER FINISHED ASSY

    MDR report key: 3102023 · Received May 3, 2013

    Report

    Report Number
    1713747-2013-00119
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 5, 2016
    Manufacturer
    OGDEN MANUFACTURING
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION AND THE FAILURE MODE CANNOT BE CONFIRMED. HOWEVER, AN 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 SPECIFICATION.

    Description of Event or Problem · 1

    A HEMODIALYSIS USER FACILTIY HAS REPORTED THAT DURING TREATMENT A BLOOD LEAK OCCURRED. SHORTLY AFTER TREATMENT BEGAN, THE LEAK WAS VISUALLY OBSERVED AND THE MACHINE ALARMED. TEST STRIPS CONFIRMED THE BLOOD LEAK. ESTIMATED BLOOD LOSS WAS 280ML'S. PATIENT HAD NO ILL EFFECTS. SAMPLE IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194919 OPTIFLUX 160NRE DIALYZER FINISHED ASSY FJI OGDEN MANUFACTURING 13BU05014

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR FRESENIUYS 2008K MACKINE