BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIALYZER, OPTIFLUX F200NR

    MDR report key: 2141567 · Received June 10, 2011

    Report

    Report Number
    2141567
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 21, 2011
    Report Date
    June 10, 2011
    Manufacturer
    FRESENIUS
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A BLOOD LEAK WAS NOTED IN THE DIALYZER (FAULTY DIALYZER) AT THE ONSET OF THE PT'S TREATMENT. THE PT LOST A CIRCUIT OF BLOOD AND THERE WAS A DELAY IN TREATMENT FROM THE TIME NEEDED TO SET UP A NEW CIRCUIT ON DIALYSIS MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIALYZER, OPTIFLUX F200NR HEMODIALYSIS DIALYZER KDI FRESENIUS * 10SU104002

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR DIALYSIS