BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESENIUS DIALYSIS MACHINE

    MDR report key: 1664420 · Received April 16, 2010

    Report

    Report Number
    MW5015596
    Event Type
    Injury
    Date Received
    April 16, 2010
    Date of Event
    April 10, 2010
    Report Date
    April 16, 2010
    Manufacturer
    FRESENIUS
    Product Code
    FII
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 24V ALARM.... ALL MACHINE FUNCTION WAS LOST DURING TREATMENT.... HAD TO USE MANUAL CRANK TO RETURN PT'S BLOOD. TREATMENT ENDED PER MD, AND THERE WAS NO PT BLOOD LOSS OR HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS DIALYSIS MACHINE FII FRESENIUS 2008-K

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention