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

Catalog Number	CON-HL-90
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was overheating and had frayed wires on the power cord.The event occurred upon power on.There was no report of patient involvement.
Additional Manufacturer Narrative
B3: date of event is unknown, no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
Received one device.Visual inspection found that the power cord was indeed damaged, and the insulation was broken.It was also observed that the reservoir cap had internal cracks at all four corners; in addition, the plug, tube cap, auxiliary seal, and rubber feet were missing, the j-clip was damaged, and the tüv label was an outdated version.The device has not undergone the pump power-on test due to the damaged power cord and to prevent damage to other components.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.

• Brand Name: LEVEL 1 HOTLINE BLOOD AND FLUID WARMER
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): ICU MEDICAL, INC.; 3350 granada avenue north; oakdale MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23279291
• Report Number: 3012307300-2025-11395
• Device Sequence Number: 20213587
• Product Code: LGZ
• UDI-Device Identifier: 50695085820909
• UDI-Public: (01)50695085820909(11)111019
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

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-90
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2011
• 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