BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    F6 DIALYZER FINISHED ASSY (CASE)

    MDR report key: 3063309 · Received March 1, 2013

    Report

    Report Number
    1713747-2013-00052
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 2013
    Manufacturer
    OGDEN MANUFACTURING
    Product Code
    FJI
    PMA / PMN Number
    K870725
    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 MANUFACTURER FOR PHYSICAL EVALUATION AND THE FAILURE MODE CANNOT BE CONFIRMED. HOWEVER, AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES 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. AT THE START OF TREATMENT, THE LEAK WAS VISUALLY OBSERVED AND THE MACHINE ALARMED. ESTIMATED BLOOD LOSS WAS 50CC'S. PATIENT HAD NO ILL EFFECTS. SAMPLE IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89965 F6 DIALYZER FINISHED ASSY (CASE) HEMODIALYSIS DIALYZER FJI OGDEN MANUFACTURING 12HU03008

    Patients

    Seq Age Sex Outcome Treatment
    1