BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 160NRE DIALYZER FINISHED ASSY

    MDR report key: 3101878 · Received May 3, 2013

    Report

    Report Number
    1713747-2013-00115
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    OGDEN MANUFACTURING
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MFR FOR PHYSICAL EVAL 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 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. IMMEDIATELY AFTER THE INITIATION OF TREATMENT, THE MACHINE ALARMED AND TEST STRIPS CONFIRMED THE BLOOD LEAK. ESTIMATED BLOOD LOSS WAS 300 CC'S. BROKEN FIBERS WERE NOTED ON THE ARTERIAL SIDE OF THE DIALYZER. NO MEDICAL INTERVENTION WAS REQUIRED AND THE PT HAD NO ADVERSE EFFECTS. SAMPLE WAS DISCARDED BY THE USER FACILITY; SAMPLE IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195177 OPTIFLUX 160NRE DIALYZER FINISHED ASSY FJI OGDEN MANUFACTURING 12SU01015

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR FRESENIUS T MACHINE