BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 180NRE DIALYZER FINISHED ASSY.

    MDR report key: 2894664 · Received December 27, 2012

    Report

    Report Number
    1713747-2012-00255
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    December 5, 2012
    Report Date
    December 5, 2012
    Manufacturer
    OGDEN MANUFACTURING
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A HEMODIALYSIS USER FACILITY HAS REPORTED THAT DURING TREATMENT A BLOOD LEAK OCCURRED. AT THE BEGINNING OF TREATMENT, BLOOD WAS OBSERVED LEAKING INTO DIALYSATE LINE. THE MACHINE ALARMED AND THE BLOOD LEAK WAS CONFIRMED USING TEST STRIPS. ESTIMATED BLOOD LOSS WAS 100 CC. THERE WERE NO PATIENT ILL EFFECTS. SAMPLE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIFLUX 180NRE DIALYZER FINISHED ASSY. HEMODIALYSSI DIALYZER FJI OGDEN MANUFACTURING 12NU01001

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR FRESENIUS K2 MACHINE