BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHOENIX

    MDR report key: 545567 · Received September 24, 2004

    Report

    Report Number
    545567
    Event Type
    Injury
    Date Received
    September 24, 2004
    Date of Event
    August 28, 2004
    Report Date
    August 30, 2004
    Manufacturer
    GAMBRO, INC.
    Product Code
    KDI
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING HEMO DIALYSIS. FOAM , AIR NOTED IN LINES. MACHINE DID NOT ALARM AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHOENIX HEMODIALYSIS MACHINE KDI GAMBRO, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Life Threatening