MAUDE Adverse Event Report: 3M COMPANY 3M¿ RANGER¿ FLUID WARMING SET, HIGH FLOW; BAIR HUGGER BLOOD/FLUID WARMER

Model Number	24370
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product has not been returned to 3m for analysis.3m is unable to verify the leak, identify exact location and root cause without the sample.3m has investigated and identified a manufacturing issue with the auto-venting bubble trap that introduces the risk of blood or fluid leaks while priming the sets and/or during fluid administration.There is no alleged injury to the patient or caregiver for this reported incident.3m has initiated a field safety corrective action for lots associated with this issue.3m has implemented a change to address the identified manufacturing issue and will continue to monitor.
Event or Problem Description
A user facility reported during a transfusion in the operating room, 3m¿ ranger¿ blood/fluid warming high flow set, 24370, failed at the hub just below the bubble trap.No injuries or medical interventions were required due to the alleged malfunction.
Additional Manufacturer Narrative
This follow-up report is being submitted to correct section d3 manufacturer name, city and state, from 3m health care to 3m company.
Additional Manufacturer Narrative
This follow-up report is being submitted to correct section d4 model # from blank to 24370, and section d4 unique identifier (udi) # from (b)(4).

• Brand Name: 3M¿ RANGER¿ FLUID WARMING SET, HIGH FLOW
• Common Device Name: BAIR HUGGER BLOOD/FLUID WARMER
• Manufacturer (Section D): 3M COMPANY; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): NYPRO PRECISION ASSEMBLIES; sor juana ines de la cruz; cd. industrial; tijuana, 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: 18342283
• Report Number: 2110898-2023-00106
• Device Sequence Number: 5414015
• Product Code: BSB
• UDI-Device Identifier: 10707387792708
• UDI-Public: 0110707387792708112205051725050510HM9213
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/07/2024

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: 05/05/2025
• Device Model Number: 24370
• Device Catalogue Number: 24370
• Device Lot Number: HM9213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2023
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/17/2023
• Supplement Report FDA Received Date: 06/01/2024; 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2022
• 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