MAUDE Adverse Event Report: 3M COMPANY 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SET; WARMER, BLOOD, NONELECTROMAGNETIC RADIATION

Model Number	24355
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The devices have not been returned to solventum for analysis; therefore, solventum is unable to verify the leak, identify exact location and root cause without the samples.Based on the problem description, a likely cause is the tubing disconnected from the spike.Possible causes include pulling on tubing instead of holding on to the spike, excessive twisting of the spike, excessive force on the tubing when removing spike from infusion bag, or insufficient bond of tubing to spike.Spike to tubing bond failure can also be caused by over pressurization of set above 300 mmhg.Solventum will continue to monitor.
Event or Problem Description
A user facility reported the tubing on two 3m¿ ranger¿ blood/fluid warming high flow sets dislodged at the base on the spike.No injuries or medical interventions were required due to the alleged malfunctions.
Additional Manufacturer Narrative
The sample was received for analysis.The reported spike to tubing disconnection was confirmed by the sample; however, a root cause could not be determined.A review of the batch record showed this lot met all specifications for product release and no deviations were found that could have caused or contributed to the reported malfunction.Solventum will continue to monitor.

• Brand Name: 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SET
• Common Device Name: WARMER, BLOOD, NONELECTROMAGNETIC RADIATION
• Manufacturer (Section D): 3M COMPANY; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): NPA DE MEXICO S. DE R.L. DE C.V.; sor juana ines de la cruz #201; 50 interior 5, cd. industrial; tijuana,baja california
• Manufacturer Contact: yvonne mcmann ; 6203 farinon drive; san antonio, TX 78249 ; 2103743188
• MDR Report Key: 24316628
• Report Number: 2110898-2026-00007
• Device Sequence Number: 20069153
• Product Code: BSB
• UDI-Device Identifier: 10707387792685
• UDI-Public: 0110707387792685112503131728031310HX9921
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K973741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2026

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 Model Number: 24355
• Device Catalogue Number: 24355
• Device Lot Number: HX9921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown