MAUDE Adverse Event Report: ICU MEDICAL, INC. LEVEL 1 FAST FLOW FLUID WARMER; WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION

Catalog Number	8002950
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter phone: ext.(b)(6).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.
Event or Problem Description
It was reported that the apparatus involved with the air detection testing was not performing the check for air bubbles.F1 fuse on the main printed circuit board is responsible for air detection/clamp and that the fuse has been blown thus leading to the inactivity of the air detection apparatus.There was no patient involvement.
Additional Manufacturer Narrative
One device was received for evaluation for the complaint that the apparatus involved with the air detection testing was not performing the check for air bubbles.F1 fuse on the main printed circuit board is responsible for air detection/clamp and that the fuse has been blown thus leading to the inactivity of the air detection apparatus.This device doesn't have event log and there was no 12-month service history during the review.The visual and functional testing was performed.The complaint can be replicated the report error by visual inspection.Found loose air detector's connector, broken drain valve, loose screw inside h31b air detector's module, and float switch was not installed properly.The probable cause of the report error is the loose air detector's power supply connector.Reseated air detector's power supply connector to resolve the report error.The h31b air detector module was repaired, replaced drain valve, and reseated float switch assembly.The device passed all functional tests after the repair.

• Brand Name: LEVEL 1 FAST FLOW FLUID WARMER
• Common Device Name: WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
• 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: 24267928
• Report Number: 3012307300-2026-00929
• Device Sequence Number: 15967226
• Product Code: BSB
• UDI-Device Identifier: 50695085829506
• UDI-Public: (01)50695085829506(11)071010
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2026
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2007
• 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