BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 180NRE DIALYZER FINISHED ASSY.

    MDR report key: 2860027 · Received December 4, 2012

    Report

    Report Number
    1713747-2012-00227
    Event Type
    Malfunction
    Date Received
    December 4, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    OGDEN MANUFACTURING
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION AND THE COMPLAINT IS CONFIRMED. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. 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. THE MACHINE ALARMED. ESTIMATED BLOOD LOSS WAS 250CC'S. NO MEDICAL INTERVENTION WAS REQUIRED. THERE IS NO OTHER KNOWN ILL EFFECT TO THE PATIENT. SAMPLE IS AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIFLUX 180NRE DIALYZER FINISHED ASSY. HEMODIALYSIS DIALYZER FJI OGDEN MANUFACTURING 12NU04001

    Patients

    Seq Age Sex Outcome Treatment
    1 FRESENIUS T MACHINE