FDA Adverse Event Malfunction Summary report: N

M WARMER SYSTEM

MDR report key: 24680859 · Received March 24, 2026

Report

Report Number: 3032580628-2026-00002
Event Type: Malfunction
Date Received: March 24, 2026
Date of Event: February 18, 2026
Report Date: March 24, 2026
Manufacturer: MEQU A/S
Product Code: LGZ
UDI-DI: 05700002076816
PMA / PMN Number: K232107
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

INVESTIGATION OF THE DEVICE IS ONGOING - A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE CONCLUSIONS OF THE ROOT CAUSE HAVE BEEN DETERMINED, IF POSSIBLE.

Description of Event or Problem · 0

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 18 G 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
743488	M WARMER SYSTEM	BLOOD AND IV FLUID WARMER	LGZ	MEQU A/S	MWS201		05700002076816

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown