BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX F160NRE

    MDR report key: 2495447 · Received March 9, 2012

    Report

    Report Number
    2495447
    Event Type
    Malfunction
    Date Received
    March 9, 2012
    Date of Event
    March 8, 2012
    Report Date
    March 9, 2012
    Manufacturer
    FRESENIUS MEDICAL CARE
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    THREE PATIENTS HAD DIALYSIS. LATER ON, WE RECEIVED A RECALL NOTICE FROM FRESENIUS MEDICAL CARE REGARDING THIS DIALYZER. THERE WAS NO HARM TO THE THREE PATIENTS. THE PRODUCT WAS REMOVED AND REPLACED WITH A NEW PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIFLUX F160NRE OPTIFLUX F160NRE HEMODIALYZER # 11PUO1012 KDI FRESENIUS MEDICAL CARE * 11PUO1012

    Patients

    Seq Age Sex Outcome Treatment
    1 *