BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTOTHERM PLUS

    MDR report key: 695229 · Received March 22, 2006

    Report

    Report Number
    695229
    Event Type
    Malfunction
    Date Received
    March 22, 2006
    Date of Event
    March 22, 2006
    Report Date
    March 22, 2006
    Manufacturer
    FUTUREMED AMERICA, INC.
    Product Code
    LGZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    THE BLOOD WARMER TUBING STARTED TO CREATE MICRO AIR BUBBLES ALONG THE TUBING WHEN THE TEMPERATURE OF THE ASTOTHERM WARMING DEVICE WENT ABOVE 37 DEGREES CENTIGRADE. WE UNDERSTAND THAT THE MANUFACTURER STATES THAT THE ASTOTHERM CAN CREATE BUBBLES WHEN COLD BLOOD PASSES THROUGH THE WARMING DEVICE, ESPECIALLY WHEN THE TEMPERATURE IS SET ABOVE 37 DEGREES. WE USED THE DEVICE AGAIN AND SET THE TEMPERATURE AT 37 DEGREES AND NOTICED FEWER BUBBLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASTOTHERM PLUS BLOOD WARMER LGZ FUTUREMED AMERICA, INC. AP220NA *
    2 ASTOTUBE TUBING, BLOOD WARMER LGZ FUTUREMED AMERICA, INC. 774 565 01 372355

    Patients

    Seq Age Sex Outcome Treatment
    1 *