MAUDE Adverse Event Report: 3M COMPANY 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SET; WARMER, BLOOD, NONELECTROMAGNETIC 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	04/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to solventum for analysis.Upon testing the sample, there was a leak at the heat exchanger.Possible causes of heat exchanger leaks include over-pressurization above 300mmhg, insertion or removal of pressurized heat exchanger from heating unit, and heat exchanger not fully inserted into the heating unit.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.
Event or Problem Description
A user facility reported a 3m¿ ranger¿ blood/fluid warming high flow set leaked while priming with saline, prior to patient use.The leak was observed from the back of the outlet port of the cassette.No injuries or medical interventions were required due to 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; tijuana,baja california 22444 ; MX 22444
• Manufacturer Contact: yvonne mcmann ; 6203 farinon drive; san antonio, TX 78249 ; 2103743188
• MDR Report Key: 22099442
• Report Number: 2110898-2025-00026
• Device Sequence Number: 7425033
• Product Code: BSB
• UDI-Device Identifier: 10707387792708
• UDI-Public: 0110707387792708112408191727081910HM9797
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/28/2025

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: HM9797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2024
• 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