MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ RANGER¿; 3M¿ RANGER¿ BLOOD/FLUID WARMING UNIT, MODEL 24500

Model Number	24500
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier, age or date of birth, sex, weight, ethnicity, and race: patient specifics are not available.Device has been returned to 3m.Solution was found inside the unit and visible water ingress markings were observed in the temperature controller.Solution on temperature controller leads created a short condition resulting in failure.Visible signs of corrosion and marks are observed inside the unit, on the screws used to hold printed circuit board in place and on the heater.Instructions for use state ranger units are ipx0 rated and precaution must be taken to prevent any liquid ingress into the unit.3m will continue to monitor.
Event or Problem Description
A facility reported a blown controller with burn marks on the interior casing and controller of 3m¿ ranger¿ fluid warming unit, model 245 upon opening the unit for service by their technician.No other observations were discovered while in use.No medical interventions were required.No patient or staff injury was alleged.

• Brand Name: 3M¿ RANGER¿
• Common Device Name: 3M¿ RANGER¿ BLOOD/FLUID WARMING UNIT, MODEL 24500
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M COMPANY; 10351 west 70th street; eden prairie MN 55344
• Manufacturer Contact: nadia battah ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6514612670
• MDR Report Key: 16396832
• Report Number: 2110898-2023-00024
• Device Sequence Number: 6384769
• Product Code: BSB
• UDI-Device Identifier: 00707387781491
• UDI-Public: 00707387781491
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/17/2023

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 Model Number: 24500
• Device Catalogue Number: 24500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown