BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 200NRE DIALYZER FINISHED ASSY.

    MDR report key: 3243175 · Received July 18, 2013

    Report

    Report Number
    1713747-2013-00268
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 2013
    Manufacturer
    OGDEN MANUFACTURING
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MFR FOR PHYSICAL EVAL AND THE FAILURE MODE CANNOT BE CONFIRMED. HOWEVER, AN INVESTIGATION OF THE DEVICE MFG RECORDS WAS CONDUCTED BY THE MFR. THERE WERE NO DEVIATIONS OR NONCONFORMANCES DURING THE MFG 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 FACILITY HAS REPORTED THAT DURING A BLOOD LEAK OCCURRED. THE EXTERNAL LEAK WAS VISUALLY OBSERVED AT THE DIALYZER HEAD. BLOOD WAS RETURNED TO THE PT AND TREATMENT WAS COMPLETED WITH A NEW DIALYZER. ESTIMATED BLOOD LOSS WAS LESS THAN 10ML'S. NO MEDICAL INTERVENTION WAS REQUIRED AND THE PT HAD NO ADVERSE EFFECTS. SAMPLE IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335409 OPTIFLUX 200NRE DIALYZER FINISHED ASSY. FJI OGDEN MANUFACTURING 13EU04006

    Patients

    Seq Age Sex Outcome Treatment
    1 FRESENIUS 5008