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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.
Event or Problem Description
It was reported that a percutaneous renal procedure (perc) was performed in room 15.The procedure required warmed irrigation.Normal saline was delivered through a level 1 fluid warmer to maintain an irrigation temperature of around 41°c; however, the machine had a cooling water leak.Midway through the procedure, the writer noticed smoke coming from the machine.It was determined that the warming function malfunctioned, causing the plastic irrigation tubing to burn.The writer immediately stopped using the machine, removed the plastic tubing, and contacted medical equipment services to assess the device.There were no adverse effects on the patient at that time.The warmed normal saline solution remained at an appropriate temperature throughout the procedure.
Additional Manufacturer Narrative
The suspected device was not received for evaluation.The complaint could not be confirmed, and a root cause was unable to be determined.A good faith effort was conducted to retrieve the device from the customer.

• 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 km21.7; carretera miguel aleman km 21; apodaca nl CP666 03; MX CP66603
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24688670
• Report Number: 3012307300-2026-02902
• Device Sequence Number: 21307988
• Product Code: BSB
• UDI-Device Identifier: 50695085829506
• UDI-Public: (01)50695085829506(11)051025
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2026

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: Other
• Device Catalogue Number: 8002950
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2005
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown