BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FI80 OPTIFLUX

    MDR report key: 1022271 · Received March 28, 2008

    Report

    Report Number
    MW5006087
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    March 27, 2008
    Report Date
    March 28, 2008
    Manufacturer
    FRESENIUS MEDICAL CARE
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS CONNECTED ON THE DIALYSIS MACHINE AND SUDDENLY THE MACHINE SCREEN READ BLOOD LEAK. DIALYZER TESTED FOR BLOOD LEAK AND RESULT TURNED OUT POSITIVE. DIALYSIS IMMEDIATELY DISCONTINUED AND BLOOD WAS NOT RETURNED. NO UNUSUAL REACTION NOTED DUE TO IMMEDIATE INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FI80 OPTIFLUX DIALYZER KDI FRESENIUS MEDICAL CARE 8BU214

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Disability OPTIFLUX ADVANCED FRESENIUS POLYSOLFONE F180NR