BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEL 1 HOTLINE BLOOD AND FLUID WARMER

    MDR report key: 19136236 · Received April 18, 2024

    Report

    Report Number
    3012307300-2024-02725
    Event Type
    Malfunction
    Date Received
    April 18, 2024
    Date of Event
    March 1, 2024
    Report Date
    June 4, 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

    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

    H6. INVESTIGATION CODES: UPDATED. INVESTIGATION SUMMARY: THE AFFECTED DEVICE WAS RETURNED FOR EVALUATION. EXTERNALLY, CRACKS WERE ONLY OBSERVED IN THE CIRCULATING WATER TANK COVER. NO ABNORMALITY RELATED TO THE REPORTED EVENT WAS CONFIRMED ON THE PRODUCT. APPEARANCE CHECK, NORMAL OPERATION CHECK & FUNCTIONAL TESTING PERFORMED. ALARM FOR NO DISPOSABLE TUBE ACTIVATES EVEN IF L-70 HEATING TUBE IS ATTACHED, CONFIRMING THE CUSTOMER'S COMPLAINT. THE ROOT CAUSE WAS A MALFUNCTION OF THE MICROSWITCH THAT DETECTS WHETHER THE L-70 TUBE IS ATTACHED OR NOT. THE MICROSWITCH AND THE TANK COVER WERE REPLACED TO CORRECT THE ISSUE. HL-90 DEVICE PASSED ALL FUNCTIONAL AND PERFORMANCE TESTS AFTER REPAIR. THE SERVICE HISTORY REVIEW IDENTIFIED THERE WAS NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CIRCUIT DISCONNECTION ALARM DID NOT DISAPPEAR EVEN AFTER INSTALLING CONSUMABLES. THE FAULT OCCURRED DURING SET UP. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2309722 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