MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® 5000; ARCTIC SUN DEVICE

Catalog Number	50000000
Medical Device Problem Code	Insufficient Heating (1287)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2026
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 notes patient temperature (pt) had dropped and water temperature (wt) was not increasing in response in an arctic sun device.Denies any alerts or alarms.Patient has been rewarming since 4:30pm.Patient temperature (pt) was 33.8c, targeted temperature (tt) was 37c, water temperature (wt) was 23c, water flow rate (wfr) was 2 l/m.3 pads connected to adult patient.System diagnostics: outlet monitor temperature (t1) was 22.8c, outlet control temperature (t2) was 22.6c, inlet temperature (t3) was 23.4c, chiller temperature (t4) was 4.1c, water flow rate (wfr) was 2 l per m, inlet pressure (ip) was -7psi, circulation pump command (cpc) was 51 percent, mixing pump command (mpc) was18 percent, heater command (hc) was 0, water reservoir level (wrl) was 5, system hours were 2932.2, pump hours were 2365.1.Nurse confirms patient was not shivering, micro shivering or seizing.Walked through stop therapy and empty pads.Drained 16 ounces of water from right drain port.Advised will call back in 30 minutes to check in on water temperature (wt).Called 3 times with no answer.Sn 1830.Nurse called back because patient temperature (pt) was still not increasing and water temperature (wt) was still low.Water temperature (wt) was registering at 17.7c.Advised they need to swap out to alternate device.Send this one to biomed labeled not heating.Sn (b)(6).Per follow up information received via phone on 27apr2026, spoke with nurse who confirmed device was exchanged and new device was heating water without issue.The same pads were in use.Only 3 pads were able to be placed on the adult patient due to colostomy bag location on patient's thigh.Per follow up information received via phone on 28apr2026, spoke with biomed who noted they would like to complete a preventative maintenance on this device.Requested tech support contact information.No evaluations completed at this time.

• Brand Name: ARCTIC SUN® 5000
• Common Device Name: ARCTIC SUN DEVICE
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville CO 80027
• Manufacturer (Section G): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville CO 80027
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 25045487
• Report Number: 1018233-2026-02792
• Device Sequence Number: 9725780
• Product Code: DWJ
• UDI-Device Identifier: 00801741080142
• UDI-Public: (01)00801741080142(11)120501
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K161602
• 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): 06/10/2026

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: 50000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2026
• Supplement Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 04/30/2026
• Supplement Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2012
• 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