MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 Arctic Sun® Temperature Management System, ArcticGel¿ Pads; Arctic Gel Pads

Catalog Number	317-09-02
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.Udi format updated with available product information per gudid.H11: sections a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that the nurse stated patient went to mri earlier.Since returning, they were having flow rate issues on the arctic sun device.Large pads in use, flow rate (fr) was.04lpm.Explained correlation between flow rate and heater capacity.Guided to diagnostics: system hours 9127, pump hours 7483, inlet pressure (ip) was -2.1psi, circulation pump command (cpc) was 100 percent, flow rate (fr) was 0.4lpm.Disconnected and reconnected pads using proper technique.No change in values, and all the clamps have a lot of bubbles in them.They opted to change the set of pads vs test each one.Pad lot ngkuy601.Please call and ask for charge nurse to arrange return of the pads.
Event or Problem Description
It was reported nurse stated patient went to mri earlier.Since returning, they were having flow rate issues on the arctic sun device.Large pads in use, flow rate (fr) was.04lpm.Explained correlation between flow rate and heater capacity.Guided to diagnostics: system hours 9127, pump hours 7483, inlet pressure (ip) was -2.1psi, circulation pump command (cpc) was 100%, flow rate (fr) was 0.4lpm.Disconnected and reconnected pads using proper technique.No change in values, and all the clamps have a lot of bubbles in them.They opted to change the set of pads vs test each one.Pad lot ngkuy601.Please call and ask for charge to arrange return of the pads.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Udi format updated with available product information per gudid.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: Arctic Sun® Temperature Management System, ArcticGel¿ Pads
• Common Device Name: Arctic Gel Pads
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer (Section G): C.R. Bard, Inc. (Covington) -1018233; 8195 industrial blvd; suite 200; covington CO 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; +1(770)784-6100
• MDR Report Key: 24442669
• Report Number: 1018233-2026-01199
• Device Sequence Number: 10212451
• Product Code: DWJ
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K142702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/07/2026

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 Catalogue Number: 317-09-02
• Device Lot Number: NGKUY601
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/25/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2026
• Supplement Date Received by Manufacturer: 04/06/2026; 08/07/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 04/07/2026; 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown