BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEL 1 HOTLINE BLOOD AND FLUID WARMER

    MDR report key: 19061028 · Received April 8, 2024

    Report

    Report Number
    3012307300-2024-02265
    Event Type
    Malfunction
    Date Received
    April 8, 2024
    Date of Event
    March 1, 2024
    Report Date
    May 14, 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

    H3 AND H6 - EVALUATION CODES: UPDATED. DEVICE EVALUATION: ONE DEVICE WAS RETURNED FOR INVESTIGATION. THE RUBBER FEET WERE MISSING FROM THE APPEARANCE. NO ABNORMALITY RELATED TO THE REPORTED EVENT WAS CONFIRMED ON THE PRODUCT. FUNCTIONAL TESTING FOUND THE ALARM FOR "NO DISPOSABLE TUBE" ACTIVATES EVEN IF L-70 HEATING TUBE IS ATTACHED. THE COMPLAINT WAS CONFIRMED. ROOT CAUSE WAS ATTRIBUTED TO THE MICROSWITCH. THE SERVICE HISTORY REVIEW IDENTIFIED THERE WAS NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD. REPLACEMENT OF THE MICRO SWITCH AND ATTACHMENT OF RUBBER FEET.

    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 ALARM DOES NOT SOUND. THE CIRCUIT IS DISCONNECTED WHILE USING THE DEVICE (WATER SPOUTS FROM THE DEVICE). EVENT OCCURRED BEFORE PATIENT IN USE, THERE WAS NO PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107440 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