MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V LEVEL 1 FAST FLOW FLUID WARMER; WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION

Catalog Number	8002950
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: one device was received for evaluation.No service history review was found.The probable cause of the customers¿ issue was overheating.Remediation was completed, the device was recalibrated to meet specification requirements, and the unit passed all performance verification tests.
Event or Problem Description
It was reported that the device was overheating and had cracked tubing.There was no reported patient involvement.

• Brand Name: LEVEL 1 FAST FLOW FLUID WARMER
• Common Device Name: WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
• Manufacturer (Section D): ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V; carretera miguel aleman km; monterrey CP666 03; MX CP66603
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23485900
• Report Number: 3012307300-2025-12170
• Device Sequence Number: 13401595
• Product Code: BSB
• UDI-Device Identifier: 50695085829506
• UDI-Public: (01)50695085829506(11)210505
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: BK020043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/06/2025

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: Health Professional
• Device Catalogue Number: 8002950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2021
• 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