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

Model Number	HL-90
Medical Device Problem Codes	Break (1069); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown; no information has been provided to date.Device evaluation: the suspected device was returned for evaluation.The customer reported issue of "the outlet was broken" was verified by visual testing.The ac plug blade was broken and burn marks were found.The ac plug blade was loose, and the base was black and burnt.The reported issue is presumed to have been caused by a broken blade on the ac plug, which led to overheating and burning.The ac power cord and related parts were replaced to correct the issue.Although this case involves a trace of fire and melted/charred components, it has been determined that the cause of the issue was a user-induced error and not attributable to design or manufacturing.The device passed all functional and delivery tests after the repair.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.
Event or Problem Description
The customer returned the device stating, ¿the outlet was broken¿; during device evaluation it was found the ac plug blade was broken and burn marks were found.The event occurred during priming at the facility.There was no reported patient involvement/harm.

• Brand Name: LEVEL 1 HOTLINE BLOOD AND FLUID WARMER
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): ICU MEDICAL, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23975682
• Report Number: 3012307300-2026-00123
• Device Sequence Number: 10609271
• Product Code: LGZ
• UDI-Device Identifier: 50695085820909
• UDI-Public: (01)50695085820909(11)031017
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 01/06/2026

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: Health Professional
• Device Model Number: HL-90
• Device Catalogue Number: HL-90JP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2003
• 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