BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEL 1 HOTLINE BLOOD AND FLUID WARMER

    MDR report key: 19172988 · Received April 24, 2024

    Report

    Report Number
    3012307300-2024-02972
    Event Type
    Malfunction
    Date Received
    April 24, 2024
    Date of Event
    March 1, 2024
    Report Date
    June 7, 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
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H6: EVALUATION CODES UPDATED. DEVICE EVALUATION: ONE DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION FOUND CRACKED IN THE CIRCULATING WATER TANK COVER. DURING THE FUNCTIONAL TESTING, THE ALARM FOR NO DISPOSABLE TUBE ACTIVATES EVEN IF L-70 HEATING TUBE IS ATTACHED. THE CAUSE WAS FOUND TO BE A MALFUNCTION OF THE MICROSWITCH THAT DETECTS WHETHER THE L-70 TUBE IS ATTACHED OR NOT. THE MICROSWITCH AND CRACKED TANK COVER WERE REPLACED.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TEMPERATURE DOES NOT RISE, WATER DOES NOT ACCUMULATE EVEN WHEN CIRCULATING WATER IS ADDED. EVENT OCCURRED BEFORE PATIENT USE, DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1329171 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