BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    F6 DIALYZER FINISHED ASSY (CASE)

    MDR report key: 3190757 · Received June 24, 2013

    Report

    Report Number
    1713747-2013-00235
    Event Type
    Malfunction
    Date Received
    June 24, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    OGDEN MANUFACTURING
    Product Code
    FJI
    PMA / PMN Number
    K870725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 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. AFTER FIVE MINUTES OF TREATMENT, THE LEAK WAS VISUALLY OBSERVED IN THE PORT OF THE BOTTOM OF THE DIALYZER AND THE MACHINE ALARMED. ESTIMATED BLOOD LOSS WAS 50 CC'S. NO MEDICAL INTERVENTION WAS REQUIRED. SAMPLE WAS DISCARDED BY THE USER FACILITY; SAMPLE IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286418 F6 DIALYZER FINISHED ASSY (CASE) FJI OGDEN MANUFACTURING 12HU03007

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR FRESENIUS 2008K MACHINE