BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M WARMER SYSTEM

    MDR report key: 24795896 · Received April 6, 2026

    Report

    Report Number
    3012602431-2026-00040
    Event Type
    Malfunction
    Date Received
    April 6, 2026
    Date of Event
    February 18, 2026
    Report Date
    April 6, 2026
    Manufacturer
    MEQU A/S
    Product Code
    LGZ
    UDI-DI
    05700002076816
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    MFR REPORT #: 3032580628-2026-00002 THE PRODUCT PROBLEM FROM NEW ZEALAND REPORTED THE M WARMER OVERHEATED AND LEAKED FLUID AFTER IT WAS DISCONNECTED FROM THE PATIENT AND LEFT RUNNING ON A BENCH. NO HARM OCCURRED TO THE PATIENT. DETAILED DESCRIPTION OF EVENT FROM REPORTER: THE MW DEVICE WAS USED TO WARM APPROXIMATELY 150-200 ML SODIUM CHLORIDE ADMINISTERED VIA GRAVITY FLOW THROUGH AN 18G CANNULA IN THE PATIENT'S FOREARM. DUE TO LOW FLOW, MANUAL PRESSURE WAS BRIEFLY APPLIED TO THE IV BAG TO INCREASE FLOW RATE. THE PATIENT WAS POSITIONED LATERALLY DURING TRANSPORT, WHICH MAY HAVE INTERMITTENTLY IMPEDED FLOW. THE USER OBSERVED NORMAL LED INDICATION DURING HEATING (RED BLINKING FOLLOWED BY SOLID GREEN). PP & MW WAS REMOVED FROM THE PATIENT AND LEFT CONNECTED ON A BENCH WITH NO FLUID CONNECTED BUT WITH PP STILL CONNECTED. THE WARMER WAS NOT CONNECTED TO THE PATIENT AT THE TIME AND BELIEVES THE NURSES LEFT THE WARMER PLUGGED INTO THE PP ON THE BENCH WITH NO FLUID GOING THROUGH IT. UPON INSPECTION THE DEVICE REMAINED INTACT BUT WAS HOT. A POOL OF BLACK LIQUID WAS OBSERVED ON THE BENCH, INDICATING INTERNAL LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848579 M WARMER SYSTEM BLOOD AND IV FLUID WARMER LGZ MEQU A/S MWS201 05700002076816

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown