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	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned to 3m for analysis.Based on the problem description, photos provided, and testing performed, a likely cause is a heat exchanger leak in the port area.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 found no deviations that could have caused or contributed to the reported malfunction.There is a downward trend for heat exchanger leaks.3m will continue to monitor.
Event or Problem Description
A user facility reported 3m¿ ranger¿ blood/fluid warming high flow set leaked at the heat exchanger port area.No injuries or medical interventions were reported due to the alleged malfunction.

• 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: nadia battah ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6514612670
• MDR Report Key: 19004448
• Report Number: 2110898-2024-00016
• Device Sequence Number: 18254143
• Product Code: BSB
• UDI-Device Identifier: 10707387792708
• UDI-Public: 10707387792708
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/29/2024

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: 06/10/2024
• Device Model Number: 24370
• Device Catalogue Number: 24370
• Device Lot Number: HM8968
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2021
• 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