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	07/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to solventum for analysis.The blue vent valve on the auto vent bubble trap was disconnected from the bubble trap when sample was received.Upon testing the sample, the alleged leak was not confirmed.The bubble trap blue vent valve is 100% inspected and tested at manufacturing site to verify functionality.The root cause of the alleged leak could not be determined.A review of the batch record showed this lot met all specification 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 the 3m¿ ranger¿ blood/fluid warming high flow set leaked during use.No injuries or medical interventions were required due to the alleged malfunction.The customer later reported the leak was at the bubble trap.

• 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 375 ; MX 375
• Manufacturer Contact: yvonne mcmann ; 6203 farinon drive; san antonio, TX 78249 ; 2103743188
• MDR Report Key: 20014061
• Report Number: 2110898-2024-00039
• Device Sequence Number: 17234007
• Product Code: BSB
• UDI-Device Identifier: 10707387792708
• UDI-Public: 0110707387792708112304181726041810HM9419
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/16/2024

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: 04/18/2026
• Device Model Number: 24370
• Device Catalogue Number: 24370
• Device Lot Number: HM9419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2024
• Initial Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2023
• 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