BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUDDY DISPOSABLE SET

    MDR report key: 12066171 · Received June 25, 2021

    Report

    Report Number
    12066171
    Event Type
    Malfunction
    Date Received
    June 25, 2021
    Date of Event
    June 17, 2020
    Report Date
    June 15, 2021
    Manufacturer
    BELMONT INSTRUMENT CORPORATION
    Product Code
    BSB
    UDI-DI
    00896128002091
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USED THE BUDDY LITE TO WARM FLUIDS (BURN PATIENT), LOADED THE CASSETTE, PRIMED THE LINE, ATTACHED IT TO THE PATIENT, AND TURNED IT ON (IVF [INTRAVENOUS FLUIDS] NOT UNDER PRESSURE, JUST WO). WHEN ON, FINALLY NOTICED FLUID LEAKING. IV LOCKED AND FLUIDS LOCKED. AFTER TRANSFER OF PT TO TRAUMA BED AND EVERYTHING SETTLED DOWN, DISCONNECTED THE BUDDY LITE FROM PT, IV WAS FLUSHED AND PATENT. BUDDYLITE DISPOSABLE SET REF 905-00010P. TUBING WAS STOPPED AND REMOVED FROM PATIENT USE. IV WAS FLUSHED WITHOUT INCIDENT AND INFUSION CONTINUED. NO DOCUMENTATION TO SUPPORT HYPOTHERMIA. ADMITTED TO ICU AND DISCHARGED, TO FOLLOW UP WITH BURN CLINIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968112 BUDDY DISPOSABLE SET WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION BSB BELMONT INSTRUMENT CORPORATION 905-00010P 20191002 00896128002091

    Patients

    Seq Age Sex Outcome Treatment
    1 17885 DA