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

Catalog Number	8002950
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 unit continuously alarmed.The event occurred during patient and there was no patient harm.
Additional Manufacturer Narrative
H3: device not received by manufacturer.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Investigation is still in progress.
Additional Manufacturer Narrative
H3/h6: the suspected device was returned for evaluation.The device was visually inspected.A functional test was performed, and the reported issue was confirmed.The cause of the reported issue was due defective pcb.As a result, the pcb was replaced.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 testing after repair.

• Brand Name: LEVEL 1 FAST FLOW 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 n.; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23744219
• Report Number: 3012307300-2025-13261
• Device Sequence Number: 18679639
• Product Code: BSB
• UDI-Device Identifier: 50695085829506
• UDI-Public: (01)50695085829506(11)160615
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2026

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 Catalogue Number: 8002950
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2021
• 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