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	07/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The devices have not been returned to solventum for analysis.Solventum is unable to verify the leaks, identify exact locations and root causes without samples.The affected lot number at the time of the events was unknown.Based on the problem description and photo provided, a likely cause is a spike to tubing connection leak.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 that during an abdominal aneurysm procedure, the 3m¿ ranger¿ blood/fluid warming high flow set separated at the spike-to-tubing connection.There were no reported injuries or medical interventions required as a result of the alleged malfunction.

• 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; baja california 22444 ; MX 22444
• Manufacturer Contact: yvonne mcmann ; 6203 farinon drive; san antonio, TX 78249 ; 2103743188
• MDR Report Key: 22777104
• Report Number: 2110898-2025-00045
• Device Sequence Number: 9621632
• Product Code: BSB
• UDI-Device Identifier: 10707387792685
• UDI-Public: 0110707387792685112302171726021710HX9373
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/11/2025

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 Expiration Date: 02/17/2026
• Device Model Number: 24355
• Device Catalogue Number: 24355
• Device Lot Number: HX9373
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2023
• 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