BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHOENIX

    MDR report key: 558361 · Received August 31, 2004

    Report

    Report Number
    MW1033127
    Event Type
    Injury
    Date Received
    August 31, 2004
    Date of Event
    August 28, 2004
    Report Date
    August 31, 2004
    Manufacturer
    GAMBRO INC.
    Product Code
    FII
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING HEMODIALYSIS, 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 FII GAMBRO INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Life Threatening