BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 180NRE DIALYZER FINISHED ASSY.

    MDR report key: 3427632 · Received September 27, 2013

    Report

    Report Number
    1713747-2013-00446
    Event Type
    Malfunction
    Date Received
    September 27, 2013
    Date of Event
    August 29, 2013
    Report Date
    August 29, 2013
    Manufacturer
    OGDEN MANUFACTURING
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. AT THE COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    A HEMODIALYSIS INPATIENT USER FACILITY HAS REPORTED THAT DURING TREATMENT A BLOOD LEAK OCCURRED. THE LEAK WAS VISUALLY OBSERVED AND THE MACHINE ALARMED. THE BLOOD LEAK WAS NOTED FIVE MINUTES INTO TREATMENT. BLOOD TEST STRIPS WERE NOT USED. ESTIMATED BLOOD LOSS WAS 100-155 CC'S. COMPLAINANT BELIEVES THE BOX OF DIALYZERS MIGHT HAVE BEEN DROPPED CAUSING DAMAGE. THERE WERE NO VISIBLE DAMAGES TO THE DIALYZER. NO MEDICAL INTERVENTION WAS REQUIRED. SAMPLE IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490396 OPTIFLUX 180NRE DIALYZER FINISHED ASSY. FJI OGDEN MANUFACTURING 13JU05005

    Patients

    Seq Age Sex Outcome Treatment
    1 FRESENIUS K2 MACHINE