BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 160NRE DIALYZER FINISHED ASSY.

    MDR report key: 3101879 · Received May 3, 2013

    Report

    Report Number
    1713747-2013-00116
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 4, 2013
    Manufacturer
    OGDEN MANUFACTURING
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED TO THE MFR FOR PHYSICAL EVAL AND THE COMPLAINT IS CONFIRMED. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MFR. THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    A HEMODIALYSIS USER FACILITY HAS REPORTED THAT DURING TREATMENT, A BLOOD LEAK OCCURRED. THE LEAK WAS VISUALLY OBSERVED AND THE MACHINE ALARMED. ESTIMATED BLOOD LOSS WAS 10 CC'S. NO MEDICAL INTERVENTION WAS REQUIRED AND THE PT HAD NO ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194899 OPTIFLUX 160NRE DIALYZER FINISHED ASSY. FJI OGDEN MANUFACTURING 13AU05014

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR FRESENIUS T MACHINE