BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEL 1 HOTLINE BLOOD AND FLUID WARMER

    MDR report key: 18531570 · Received January 17, 2024

    Report

    Report Number
    2183161-2024-00059
    Event Type
    Malfunction
    Date Received
    January 17, 2024
    Date of Event
    December 1, 2023
    Report Date
    March 11, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    LGZ
    UDI-DI
    50695085820909
    PMA / PMN Number
    K001764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    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

    IT HAS BEEN DETERMINED THAT COMPLAINT FILE (B)(4) WITH A MANUFACTURING REPORT NUMBER OF 2183161-2024-00059-00 IS A DUPLICATE COMPLAINT ENTERED IN ERROR. PLEASE DISREGARD THE PREVIOUS SUBMISSION(S). ANY ADDITIONAL REPORTING WILL BE CONDUCTED UNDER THE APPLICABLE FILE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE WARMER FLUID LEVEL INDICATOR WAS BROKEN. THE PRODUCT FAULT OCCURRED DURING TESTING AND NO PATIENT OR CLINICAL INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1667527 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