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

Catalog Number	317-09
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the nurse stated they started therapy this morning.The arctic sun device was alarming low flow 01/02 and current water flow rate (wfr) was 0.2 l/min.They have made sure the tubing was straight and tried connecting pads to a different port.Confirmed they were using large pads.Nurse emptied pads and disconnected, informed nurse to reconnect with proper technique.Resumed therapy, pads primed to water flow rate (wfr) was 0.Had nurse stop, empty pads, and disconnect pads.Device alarmed 07, empty pads not complete.Nurse disconnected over a container.Walked through enabling manual control and started.Diagnostics showed that the water flow rate (wfr) was 1.8 l/min, inlet pressure (ip) was -7.2psi, circulation pump command (cpc) was 47 percentage, system hours 1,413, pump hours 0.Added left leg pad water flow rate (wfr) was 2.1 l/min, inlet pressure (ip) was -5.5 psi, and circulation pump command (cpc) was 65 percentage.Add right leg water flow rate (wfr) was 2 l/min, inlet pressure (ip) was -6.6 psi, and circulation pump command (cpc) was 65 percentage.Added right chest pad water flow rate (wfr) was 2.2 l/min, inlet pressure (ip) was -6.3psi, and circulation pump command (cpc) was 81 percentage.Added left chest pad water flow rate (wfr) was 0.6 l/min, inlet pressure (ip) was -7.2 psi, circulation pump command (cpc) was 25 percentage.Informed nurse this chest pad seems to be the issue.Suggested nurse to swap out the pads, they did not have universal pads to exchange just the chest pad.Walked through disabling manual control.Nurse would swap pads and call back if they are still having issues, (b)(6).
Additional Manufacturer Narrative
Initial reporter complete facility name: (b)(6), medical center ((b)(6)).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 Pads
• Manufacturer (Section D): MEDIVANCE -1725056; 321 south taylor ave; suite 200; louisville CO 80027
• Manufacturer (Section G): MEDIVANCE -1725056; 321 south taylor ave; suite 200; louisville CO 80027
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; +1(770)784-6100
• MDR Report Key: 24918009
• Report Number: 1018233-2026-02572
• Device Sequence Number: 13403024
• Product Code: DWJ
• UDI-Device Identifier: 00801741080104
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/22/2026

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
• 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: 04/15/2026
• Supplement Date Received by Manufacturer: 07/22/2026
• Initial Report FDA Received Date: 04/17/2026
• 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): 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