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
Additional Manufacturer Narrative
Patient specifics are unknown.Date of event is unknown.Initial reporter occupation is unknown.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¿ will continue to monitor.
Event or Problem Description
A hospital alleged the 3m¿ ranger¿ high flow warming set (model 24355) lot hx9181 leaked during use.No patient or staff injury was alleged.No medical interventions were required.
Additional Manufacturer Narrative
Leak location was reported to be at the bubble trap.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.
Additional Manufacturer Narrative
Mdr-2110898-2022-00102 submitted on 24-oct-2022 noted the following: e1 initial reporter: 1.Name: (b)(6).2.Address: (b)(6).Telephone:(b)(6).G2 report source: foreign.G3 date received by manufacturer: 03-oct-2022.Corrections e1 initial reporter: 1.Name: (b)(6).2.Address: (b)(6).Telephone: (b)(6).G2 report source: foreign was unselected as not applicable.G3 date received by manufacturer: 07-oct-2022.Based on the corrections provided, 3m's assessment remains the same; the 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¿ 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: 15659724
• Report Number: 2110898-2022-00102
• Device Sequence Number: 17609235
• Product Code: BSB
• UDI-Device Identifier: 00707387781446
• UDI-Public: 00707387781446
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/08/2022

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2022
• Supplement Date Received by Manufacturer: 10/07/2022; 11/30/2022
• Initial Report FDA Received Date: 10/24/2022
• Supplement Report FDA Received Date: 10/25/2022; 12/08/2022
• 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