BEUDAMED
    FDA Adverse Event Other Summary report: N

    BAXTER BM25

    MDR report key: 556371 · Received August 24, 2004

    Report

    Report Number
    MW1033422
    Event Type
    Other
    Date Received
    August 24, 2004
    Date of Event
    August 20, 2004
    Report Date
    August 24, 2004
    Manufacturer
    BAXTER
    Product Code
    FII
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INVESTIGATION ONGOING-RESULTS PENDING. ADVERSE EVENT DUE TO POSSIBLE MACHINE MALFUNCTION RELATED TO TRANSDUCER FAILURE. REPORT WILL BE AMENDED AS INDICATED UPON COMPLETION OF INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER BM25 CONTINUOUS VENO-VENOUS HEMOFILTRATION UNIT FII BAXTER BM25 *

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Other