BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 200NR DIALYZER FINISHED ASSBLY

    MDR report key: 3130340 · Received May 22, 2013

    Report

    Report Number
    1713747-2013-00151
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 24, 2013
    Manufacturer
    OGDEN MANUFACTURING
    Product Code
    KDI
    PMA / PMN Number
    K002277
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED TO THE MFR FOR PHYSICAL EVAL AND THE COMPLAINT IS CONFIRMED WITH A PU SILVER BETWEEN THE CAVITY ID END O-RING AND PU CUT SURFACE. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MFR. 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 FACILITY HAS REPORTED THAT DURING TREATMENT A BLOOD LEAK OCCURRED. WHEN REMOVING THE PT FROM THE MACHINE, THE NURSE NOTICED DROPS OF BLOOD ON THE OUTSIDE OF THE DIALYZER NEAR THE HEADER. THE LEAK WAS VISUALLY OBSERVED AND THE MACHINE ALARMED. ESTIMATED BLOOD LOSS WAS LESS THAN 5ML'S. SAMPLE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226587 OPTIFLUX 200NR DIALYZER FINISHED ASSBLY KDI OGDEN MANUFACTURING 13BU04008

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR FRESENIUS HEMODIALYSIS MACHINE