BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX

    MDR report key: 4976090 · Received July 29, 2015

    Report

    Report Number
    4976090
    Event Type
    Malfunction
    Date Received
    July 29, 2015
    Date of Event
    July 6, 2015
    Report Date
    July 29, 2015
    Manufacturer
    FRESENIUS MEDICAL CARE
    Product Code
    JQQ
    Product Problem
    Yes
    Report Source
    User Facility report

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493666 OPTIFLUX HEMODIALYSIS DIALYZER JQQ FRESENIUS MEDICAL CARE * 15BU06016

    Patients

    Seq Age Sex Outcome Treatment
    0 47 YR