BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 160NRE DIALYZR FINISHED ASSY.

    MDR report key: 2882960 · Received December 18, 2012

    Report

    Report Number
    1713747-2012-00236
    Event Type
    Malfunction
    Date Received
    December 18, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 21, 2012
    Manufacturer
    OGDEN MANUFACTURING
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A HEMODIALYSIS USER FACILITY HAS REPORTED THAT DURING TREATMENT A BLOOD LEAK OCCURRED. BLOOD FOUND TO BE LEAKING AROUND ARTERIAL CAP DURING PATIENT'S TREATMENT. PATIENT ON MACHINE FOR GREATER THAN ONE HOUR. THE LEAK WAS VISUALLY OBSERVED. ESTIMATED BLOOD LOSS WAS 300CC'S. THERE WERE NO PATIENT ILL EFFECTS. SAMPLE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIFLUX 160NRE DIALYZR FINISHED ASSY. HEMODIALYSIS DIALYZER FJI OGDEN MANUFACTURING 12LU03006

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR FRESENIUS K MACHINE