MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ RANGER¿ FLUID WARMING SET, HIGH FLOW; HIGH FLOW DISPOSABLE TUBING

Catalog Number	24355
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A hospital alleged multiple 3m¿ ranger¿ high flow warming sets (model 24355) leaked at the bubble trap.No patient or staff injury was alleged.No medical interventions were required.
Additional Manufacturer Narrative
Patient specifics are unknown.Date of event was reported to be the last couple months.Product has not been returned to 3m¿ for analysis.It is unknown if the maximum dynamic operating pressure of 300mmhg was exceeded when the leaks occurred.Squeeze ball tubing was reported to have been used on some.To reduce the risk of leaks, all instructions should be followed as per the instructions for use (ifu).The instructions for use states, the pressure infuser system can accept 250 ml to 1000 ml fluid bags and provides maximum dynamic operating pressure of 300 mmhg.3m¿ is unable to verify the leak and root cause without the sample.3m¿ will continue to monitor.
Additional Manufacturer Narrative
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.

• Brand Name: 3M¿ RANGER¿ FLUID WARMING SET, HIGH FLOW
• Common Device Name: HIGH FLOW DISPOSABLE TUBING
• Manufacturer (Section D): 3M HEALTH CARE; 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: dianne gibbs ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6517379117
• MDR Report Key: 15632159
• Report Number: 2110898-2022-00110
• Device Sequence Number: 14942506
• Product Code: BSB
• UDI-Device Identifier: 00707387781446
• UDI-Public: 00707387781446
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2022

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: 03/09/2025
• Device Catalogue Number: 24355
• Device Lot Number: HX9181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2022
• Supplement Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 10/19/2022
• Supplement Report FDA Received Date: 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2022
• 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