MAUDE Adverse Event Report: ICU MEDICAL, INC. LEVEL 1 HOTLINE FLUID WARMER, 390; WARMER, THERMAL, INFUSION FLUID

Catalog Number	CON-HL-390
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device displayed an over temperature alarm.
Additional Manufacturer Narrative
One device was received for investigation.The device was functionally tested, but the investigation could not duplicate the reported issue.The investigation did identify that the device microswitch was broken.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.Based on the results of the investigation, the reported complaint could not be confirmed.The device microswitch was replaced and the device passed all testing.

• Brand Name: LEVEL 1 HOTLINE FLUID WARMER, 390
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): ICU MEDICAL, INC.; 201 west queen street; southington CT
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 60045 ; 2247062300
• MDR Report Key: 23657477
• Report Number: 1526863-2025-00146
• Device Sequence Number: 15983556
• Product Code: LGZ
• UDI-Device Identifier: 10695085002796
• UDI-Public: (01)10695085002796(11)260424
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K911383
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 11/26/2025

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: CON-HL-390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown