BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEL 1 HOTLINE BLOOD AND FLUID WARMER

    MDR report key: 18924151 · Received March 18, 2024

    Report

    Report Number
    3012307300-2024-01441
    Event Type
    Malfunction
    Date Received
    March 18, 2024
    Date of Event
    February 1, 2024
    Report Date
    April 24, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    LGZ
    UDI-DI
    50695085820909
    PMA / PMN Number
    K911383
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT IS UNKNOWN, NO INFORMATION HAS BEEN PROVIDED TO DATE. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    ONE DEVICE WAS RECEIVED FOR INVESTIGATION. THE DEVICE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. THE REPORTED COMPLAINT WAS DUPLICATED AS AN ALARM FOR "NO DISPOSABLE TUBE" ACTIVATES EVEN IF L-70 HEATING TUBE IS ATTACHED. THE COMPLAINT IS CONFIRMED. THE CAUSE IS A MALFUNCTION OF THE MICROSWITCH THAT DETECTS WHETHER THE L-70 TUBE IS ATTACHED OR NOT. THIS WILL BE REPLACED. THE PRODUCT'S HISTORY RECORDS WERE REVIEWED AND THERE WERE NO NON-CONFORMANCES NOR SERVICE-RELATED ISSUES THAT WOULD HAVE RESULTED IN THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE TURNED ON THE DEDICATED CIRCUIT CORRECTLY, BUT THE HEATING TUBE INSTALLATION CONFIRMATION LAMP CAME ON AND THE ALARM WENT OFF. EVENT OCCURRED BEFORE PATIENT IN USE, THERE WAS NO PATIENT INVOLVEMENT. NO HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957065 LEVEL 1 HOTLINE BLOOD AND FLUID WARMER WARMER, THERMAL, INFUSION FLUID LGZ SMITHS MEDICAL ASD, INC. HL-90 50695085820909

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown