BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M WARMER SYSTEM

    MDR report key: 24755104 · Received April 1, 2026

    Report

    Report Number
    3032580628-2026-00003
    Event Type
    Injury
    Date Received
    April 1, 2026
    Date of Event
    March 4, 2026
    Report Date
    April 1, 2026
    Manufacturer
    MEQU A/S
    Product Code
    LGZ
    UDI-DI
    05700002076823
    PMA / PMN Number
    K232107
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEFECT DEVICE HAS NOT BEEN RETURNED TO MANUFACTURER YET. INVESTIGATION WILL BE PERFORMED WHEN THE DEFECT DEVICE HAS BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE.

    Description of Event or Problem · 0

    THE EVENT REPORTED THAT THE M WARMER OVERHEATED DURING A TRAINING EXERCISE CAUSING ACTUAL INJURIES TO THE PATIENT (ROLE PLAYER WHO IS A PROFESSIONAL). THE CASE ITSELF WAS IN DIRECT CONTACT WITH THE PATIENT'S FOREARM (THIS OCCURRED DURING VEHICLE TRANSPORT) AND CAUSED LOCALIZED 2ND DEGREE BURNS. THE HEALTHCARE PROVIDER IMMEDIATELY PULLED OUT THE IV LINE BUT THE CATHETER HAD ALREADY PARTIALLY MELTED. THE INTRAVENOUS PIECE COLLAPSED ON ITSELF AND THE EXTERNAL PIECE CAUSED A LOCALIZED 2ND DEGREE BURN. THE M WARMER WAS SMOKING AND CRACKLING, AND THE CASE WAS SWOLLEN AND DEFORMED. IT REMAINED BURNING HOT FOR A WHILE AND MELTED THE PLASTIC BAG IT WAS IN EVEN AN HOUR LATER. THE FLUID IN THE LINE GOT OVERHEATED IN THE PROCESS, WHICH CAUSED THE CATHETER ITSELF TO ALSO CAUSE A LOCALIZED 2ND DEGREE BURN IN THE LEFT ANTECUBITAL FOSSAE. THE PATIENT DESCRIBED FEELING SEVERE PAIN GOING UP ALONG HER UPPER ARM, THEN EXPERIENCED DISTAL NUMBNESS IN HER HAND AND FOREARM WHICH GOT WORSE OVER SEVERAL HOURS AND IS PRESENT AND UNCHANGED SEVERAL DAYS LATER. THERE IS A CONCERN FOR UPPER EXTREMITY THROMBOSIS VS NERVE INJURY. ADDITIONAL INFORMATION FROM THE REPORTER (27-MAR-2026) INFORMED THAT SCLEROTHERAPY WAS CONDUCTED ON THE PATIENT. THE PATIENT IS IN PROGRESS OF RECOVERING (NOT YET FULLY RECOVERING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814434 M WARMER SYSTEM BLOOD AND IV FLUID WARMER LGZ MEQU A/S MWS201 05700002076823

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female Other