BEUDAMED
    FDA Adverse Event Other Summary report: N

    H-1200/H-31B FAST FLOW WARMER

    MDR report key: 648429 · Received December 2, 2005

    Report

    Report Number
    1221261-2005-00029
    Event Type
    Other
    Date Received
    December 2, 2005
    Date of Event
    November 4, 2005
    Report Date
    December 2, 2005
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    LGZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    USER ALLEGES THAT WHEN TRANFUSING BLOOD PRODUCTS TO A PT THE SMALL BUBBLES DO NOT VENT AND THESE SWIRLING BUBBLES TRIGGER THE CLAMP REPETITIVELY. THIS HAPPENED REPEATEDLY WHEN NEW GAS VENT FILTERS WERE INSTALLED AND LIMITED THE VOLUME THEY WERE ABLE TO GIVE A CRITICALLY ILL PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 H-1200/H-31B FAST FLOW WARMER FAST FLOW FLUID WARMER LGZ SMITHS MEDICAL ASD, INC. H-1200/H-31B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO