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

Model Number	24370
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility reported at least five 3m¿ ranger¿ blood/fluid warming high flow sets leaked at the section of tubing on the patient side of the bubble trap.No injuries or medical interventions were required due to the alleged malfunction.
Additional Manufacturer Narrative
The devices have not been returned to solventum for analysis.Solventum is unable to verify the leak, identify exact location and root cause without the samples.Based on the problem description and diagram provided, a likely cause are leaks at the bubble trap to tubing connection.Possible causes include pulling on tubing, excessive twisting of tubing, excessive force on tubing, or insufficient bond of tubing to bubble trap.Tubing bond failure can also be caused by over pressurization of set above 300 mmhg.Solventum will continue to monitor.

• Brand Name: 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SET
• Common Device Name: WARMER, BLOOD, NON-ELECTROMAGNETIC 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 22444 ; MX 22444
• Manufacturer Contact: yvonne mcmann ; 6203 farinon drive; san antonio, TX 78249 ; 2103743188
• MDR Report Key: 21599430
• Report Number: 2110898-2025-00016
• Device Sequence Number: 8925023
• Product Code: BSB
• UDI-Device Identifier: 10707387792708
• UDI-Public: 0110707387792708112409131727091310HM9822
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2025

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 Model Number: 24370
• Device Catalogue Number: 24370
• Device Lot Number: HM9822
• 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: 02/19/2025
• Initial Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2024
• 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