MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V LEVEL 1 HOTLINE BLOOD AND FLUID WARMER; WARMER, THERMAL, INFUSION FLUID

Catalog Number	HL-90
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspected device was available for evaluation.The device was visually inspected and found that there was a broken power on/off switch.The customer reported issue was confirmed.Found burn at power on/off switch from soldering/broke off, cracked case assembly at bottom of elbow drain tube.Replaced main board assembly kit to resolve the report error.Additionally, replaced case assembly, pole clamp mount assembly, float switch assembly, oring, ac cable, labels.The service history review had no indication that the complaint was related to a service of the device within the review period.The device passed all functional tests after the repair.
Event or Problem Description
It was reported that the unit smells like plastic when tuned on, the traces on the main board have melted.There was no reported patient involvement.

• Brand Name: LEVEL 1 HOTLINE BLOOD AND FLUID WARMER
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V; carretera miguel aleman km21.7; apodaca nl ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24414181
• Report Number: 3012307300-2026-01559
• Device Sequence Number: 5878108
• Product Code: LGZ
• UDI-Device Identifier: 50695085820909
• UDI-Public: (01)50695085820909(11)060129
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K911383
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: HL-90
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2006
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown