BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 160NRE DIALYZER FINISHED ASSY.

    MDR report key: 3882871 · Received April 4, 2014

    Report

    Report Number
    1713747-2014-00163
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Date of Event
    February 28, 2014
    Report Date
    March 7, 2014
    Manufacturer
    OGDEN MANUFACTURING
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PLANT INVESTIGATION HAS NOT YET BEEN COMPLETED. A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    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 FIRST FIVE MINUTES OF TREATMENT, AND WAS NOT RETURNED TO THE PT. ESTIMATED BLOOD LOSS WAS 250CC'S. PT REQUIRED NO MEDICAL INTERVENTION. SAMPLE HAS NOT BEEN RETURNED TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204753 OPTIFLUX 160NRE DIALYZER FINISHED ASSY. FJI OGDEN MANUFACTURING 13SU06021

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR FRESENIUS 2008K MACHINE