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

Catalog Number	60000000
Medical Device Problem Codes	Inaccurate Flow Rate (1249); Failure to Pump (1502)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2026
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 they just started cooling and were getting a low flow alarm (alarm 02) in an arctic sun device.Directed nurse to the system diagnostics.Flow rate (fr) was 1lpm, inlet pressure (ip) was -7.1psi, circulation pump command (cpc) was 28 percentage.Explained flow and inlet pressure (ip) are within specification now.They device might have been taking longer than normal to prime earlier.Therapy continued.They were getting a low flow alarm on device again.Flow rate (fr) was 0lpm, inlet pressure (ip) was -7.3psi, circulation pump command (cpc) was 5 percentage.They have check for kinks and confirmed the pad is connected properly.Asked nurse to empty pads.Nurse received alarm 07 (empty pad cycle not complete).Disconnected pad.Placed device in manual mode.Flow rate (fr) was 0lpm, inlet pressure (ip) was -6.7psi, circulation pump command (cpc) was 0 percentage.Cv 1.Pump hours were 186.7 and system hours were 2676.3.Asked nurse to send device to biomed and change to another device.Described how to adjust the cooling duration on the new device to match where they are in therapy.Per follow up information received via task on 29may2026, spoke with biomed who confirmed device had a failed circulation pump.It would start to engage, rattle a bit, then stop.They would order a new pump to replace onsite.

• Brand Name: ARCTIC SUN STAT
• 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: 25410142
• Report Number: 1018233-2026-03690
• Device Sequence Number: 10302776
• Product Code: DWJ
• UDI-Device Identifier: 00801741161513
• UDI-Public: (01)00801741161513(11)221017
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/15/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2026
• Supplement Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 06/05/2026
• Supplement Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2022
• 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