BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 160NRE DIALYZER FINISHED ASSY.

    MDR report key: 3190457 · Received June 21, 2013

    Report

    Report Number
    1713747-2013-00231
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 31, 2013
    Manufacturer
    OGDEN MANUFACTURING
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION AND THE COMPLAINT IS CONFIRMED WITH TWO LOOSE / BROKEN FIBERS NEAR THE OUTER PERIMETER ON THE NON CAVITY ID END OF THE DIALYZER. 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 INPATIENT USER FACILITY HAS REPORTED THAT DURING TREATMENT A BLOOD LEAK OCCURRED. THE LEAK WAS VISUALLY OBSERVED WITHIN THE DIALYSATE AND THE MACHINE ALARMED. BLOOD STRIPS WERE USED TWICE AND THEY TESTED NEGATIVE. ESTIMATED BLOOD LOSS WAS 200-250 CC'S. PATIENT HAD NO ADVERSE EFFECTS. SAMPLE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283719 OPTIFLUX 160NRE DIALYZER FINISHED ASSY. FJI OGDEN MANUFACTURING 13DU06006

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR FRESENIUS 2008T MACHINE