BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 200NRE DIALYZER FINISHED ASSY

    MDR report key: 2901393 · Received December 18, 2012

    Report

    Report Number
    1713747-2012-00237
    Event Type
    Malfunction
    Date Received
    December 18, 2012
    Date of Event
    September 25, 2012
    Report Date
    November 21, 2012
    Manufacturer
    OGDEN MFG
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A MAUDE EVENT REPORT, (B)(6), WAS RECEIVED FROM THE (B)(4) WHICH STATED THAT A HEMODIALYSIS USER FACILITY HAS REPORTED THAT DURING TREATMENT A BLOOD LEAK OCCURRED. AS SOON AS TREATMENT STARTED NOTICED A BLOOD LEAK ON THE DIALYZER AND HANSEN. TREATMENT WAS STOPPED AND THE LINES WERE DISCONNECTED. THE BLOOD LEAK WAS CONFIRMED WITH TEST STRIPS. THERE IS NO REPORT OF PT ILL EFFECT. SAMPLE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIFLUX 200NRE DIALYZER FINISHED ASSY HEMODIALYSIS DIALYZER FJI OGDEN MFG 12JU02002

    Patients

    Seq Age Sex Outcome Treatment
    1