BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOTLINE FLUID WARMING DEVICE SET

    MDR report key: 427200 · Received November 6, 2002

    Report

    Report Number
    MW1026700
    Event Type
    Injury
    Date Received
    November 6, 2002
    Date of Event
    November 5, 2002
    Report Date
    November 6, 2002
    Manufacturer
    RESPIRATORY SUPPORT PRODUCTS TIJUANA, MX FOR LEVEL 1, INC.
    Product Code
    LGZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ND, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HOT LINE SYSTEM FOUND TO HAVE LEAK IN INNER TUBING RESULTING IN A BREAK IN STERILE TO NON-STERILE BARRIER AND MIXING OF NON-STERILE WARMING FLUIDS WITH THE STERILE FLUIDS THE PT WAS RECEIVING VIA INNER TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOTLINE FLUID WARMING DEVICE SET FLUID WARMING DEVICE LGZ RESPIRATORY SUPPORT PRODUCTS TIJUANA, MX FOR LEVEL 1, INC. RE FL-70 2002 02 BM

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Life Threatening| R