MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS; ARCTIC GEL COOLING KIT

Catalog Number	317-07-02
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that in new therapy, arctic sun device primed and stopped.Flow rate (fr) was 0lpm.Guided to diagnostics, system hours 1719, pump hours 1422, inlet pressure (ip) was -0.7psi, circulation pump command (cpc) was 100%, flow rate (fr) was 0lpm.Adjusted tubing, disconnected and reconnected using proper technique.Device primed and stopped.No other devices available per nurse.Stopped therapy, drained/disconnected pads and placed device in manual control, inlet pressure (ip) was -7psi, circulation pump command (cpc) was 55%, inlet pressure (ip) was 1.6lpm.Added pads back one at a time and inlet pressure (ip) would never get above -1.1lpm, circulation pump command (cpc) was 100% all pads, inlet pressure (ip) would not get above.08lpm.They were changing the full set of pads rather than do more troubleshooting.Disabled manual control.Contact day charge nurse for pad return (ngkq3434).
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.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS
• Common Device Name: ARCTIC GEL COOLING KIT
• 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 ; 7707846100
• MDR Report Key: 23328838
• Report Number: 1018233-2025-09306
• Device Sequence Number: 9909521
• Product Code: DWJ
• UDI-Device Identifier: 00801741080081
• UDI-Public: (01)00801741080081(11)250511(17)270228(10)NGKQ3434
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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
• Report Date (Section B): 04/29/2026

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: 317-07-02
• Device Lot Number: NGKQ3434
• 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: 10/12/2025
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/11/2025
• 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