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)
Date of Event	08/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 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
Report received via medwatch form mw (b)(4).A hospital reported that when infusing ffp [fresh frozen plasma] and blood with use of 3m¿ ranger¿ fluid warming sets, high flow (model 24355) lot hx9190, the air chamber from two warmers allegedly "exploded," reportedly causing the ffp and blood to spill onto the floor.

• 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 1000
• 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 55144-1000 ; 6514612670
• MDR Report Key: 16081284
• Report Number: 2110898-2022-00126
• Device Sequence Number: 6093169
• 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
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/31/2022

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: Other
• Device Expiration Date: 03/25/2025
• Device Catalogue Number: 24355
• Device Lot Number: HX9190
• 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: 12/02/2022
• Initial Report FDA Received Date: 12/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2022
• 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