BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESENIUS D MACHINE

    MDR report key: 430358 · Received November 27, 2002

    Report

    Report Number
    430358
    Event Type
    Injury
    Date Received
    November 27, 2002
    Date of Event
    September 18, 2002
    Report Date
    October 9, 2002
    Manufacturer
    FRESENIUS
    Product Code
    FII
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BLOOD DETECTOR ALARM DID NOT ALARM ON A BLOOD LEAK. UPON INSPECTION IT WAS FOUND THAT THE BLOOD LEAK SENSOR WAS DISPLACED YET MACHINE 'TESTED OUT' PRIOR TO TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS D MACHINE HEMODIALYSIS MACHINE FII FRESENIUS FRESENIUS A 2008D *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization MACHINE HAD BEEN USED WITHOUT VITAL PROBLEM| SEVERAL TIMES.