BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 160NRE EIALYZER FINISHED ASSY.

    MDR report key: 3131243 · Received May 23, 2013

    Report

    Report Number
    1713747-2013-00153
    Event Type
    Malfunction
    Date Received
    May 23, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    OGDEN MANUFACTURING
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MFR FOR PHYSICAL EVALUATION AND THE FAILURE MODE CANNOT BE CONFIRMED. HOWEVER, AN INVESTIGATION OF THE DEVICE MANUFACTURING 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 TREATMENT A BLOOD LEAK OCCURRED. THERE WAS NO VISIBLE SIGN OF BLOOD ON THE TUBING AND THE LINE TESTED POSITIVE OF BLOOD WITH TEST STRIP. THE LINE WAS CLAMPED AND THE PT DISCONNECTED. THERE WERE NO PT ILL EFFECTS AND THE ESTIMATED BLOOD LOSS WAS 200ML'S. SAMPLE IS NOT AVAILABLE; SAMPLE WAS NOT SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228676 OPTIFLUX 160NRE EIALYZER FINISHED ASSY. FJI OGDEN MANUFACTURING 13AU01012

    Patients

    Seq Age Sex Outcome Treatment
    1 HEMODIALYSIS MACHINE