BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 160NRE DIALYZER FINISHED ASSY

    MDR report key: 3202173 · Received June 28, 2013

    Report

    Report Number
    1713747-2013-00239
    Event Type
    Malfunction
    Date Received
    June 28, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 2013
    Manufacturer
    OGDEN MFG
    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 DEVICE WAS NOT RETURNED TO THE MFR FOR PHYSICAL EVALUATION, 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 NONCONFORMANCE 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 INPATIENT USER FACILITY HAS REPORTED THAT DURING TREATMENT A BLOOD LEAK OCCURRED. THE LEAK WAS NOT VISUALLY OBSERVED AND THE MACHINE ALARMED; BLOOD TEST STRIPS TESTED POSITIVE. ESTIMATED BLOOD LOSS WAS 250 - 300CC'S. PT HAD NO ADVERSE EFFECTS. SAMPLE HAS NOT BEEN RETURNED TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295061 OPTIFLUX 160NRE DIALYZER FINISHED ASSY FJI OGDEN MFG 13DU03012

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR FRESENIUS 2008K2 MACHINE