MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 Arctic Sun Stat; Arctic Sun Device

Catalog Number	60000000
Medical Device Problem Code	Insufficient Heating (1287)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2026
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: 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.
Event or Problem Description
It was reported that the during rewarming in normothermia.Patient has been on therapy since 9am in an arctic sun device.Clinical staff advising biomed that the patient temperature (pt) and water temperature (wt) has not been increasing this entire time.Patient temperature (pt) was 35.5c, targeted temperature (tt) was 37c, water temperature (wt) was 29.5c, water flow rate (wfr) was 3.1 l/m.System diagnostics showed that the outlet monitor temperature (t1) was 29.8c, outlet control temperature (t2) was 29.7c, inlet temperature (t3) was 29.5c, chiller temperature (t4) was 4c, water flow rate (wfr) was 3.1 l/m, inlet pressure (ip) was -7psi, circulation pump command (cpc) was 70 percentage, mixing pump command (mpc) was 0, heater was 6 percentage, water reservoir level (wrl) was 3, system hours were 104.3 and pump hours were 60.8.Walked through stop therapy and walked through setting up rewarming in hypothermia.Rewarm from 35.5c at 0.25c/hr to 37c.Restarted therapy and water flow rate (wfr) was stabilized at 3.2 l/m.Advised they will call back in 30 minutes to check in and confirm if water temperature (wt) has increased into the 30s.Biomed advised that water temperature (wt) was registering at 24.3 system diagnostics showed that the water flow rate (wfr) was 3 l/m, inlet pressure (ip) was -6.9psi, circulation pump command (cpc) was 69 percentage, mixing pump command (mpc) was 0, heater was 0.Advised swapping out to alternate device because heater was not engaged and water temperature (wt) has dropped 5c in the last 30 minutes.Send to biomed for evaluation.Discussed adding warm blankets or bair huggers if not contraindicated in their protocol.Encouraged them to call back with any questions.

• Brand Name: Arctic Sun Stat
• Common Device Name: Arctic Sun Device
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer (Section G): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; +1(770)784-6100
• MDR Report Key: 25527326
• Report Number: 1018233-2026-03910
• Device Sequence Number: 15861522
• Product Code: DWJ
• UDI-Device Identifier: 00801741161513
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K200225
• 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
• Report Date (Section B): 07/20/2026

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: 60000000
• Was Device Available for Evaluation?: No
• 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: 06/10/2026
• Supplement Date Received by Manufacturer: 07/20/2026
• Initial Report FDA Received Date: 06/16/2026
• Supplement Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown