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

Catalog Number	317-07-02
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2026
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 they could not get a flow rate with the arctic gel pads.Tried switching device and still could not get flow.Per additional information updated from ttm on 19feb2026, they were unable to get a flow rate.They have already changed the arctic sun device, made sure there were no kinks, and the confirmed the reservoir was full.They were currently trying s/n (b)(6).Flow rate (fr) was 0lpm, inlet pressure (ip) was -0.1psi, circulation pump command (cpc) was 100%.System hours 3969.Pump hours 455.Stopped therapy.Emptied and disconnected pads.Started manual mode, flow rate (fr) was 1.7lpm, inlet pressure (ip) was -7.1psi, circulation pump command (cpc) was 54%.Connected pads one at a time.Lot for full set of medium pads was ngkw1608.Universal pad ngku1400.Connected universal pad.Flow rate (fr) was 0.5lpm, inlet pressure (ip) was -7.2psi, circulation pump command (cpc) was 29%.Connected left chest pad.Flow rate (fr) was 1.2lpm, inlet pressure (ip) was -7.3psi, circulation pump command (cpc) was 39%.Connected left thigh pad.Flow rate (fr) was 0lpm, inlet pressure (ip) was -0.3psi, circulation pump command (cpc) was 100%.Removed left thigh pad.Connected right chest pad, flow rate (fr) was 0lpm, inlet pressure (ip) was -1.7psi, circulation pump command (cpc) was 100%.Device sounded with alarm 01 (fluid delivery line open).Removed right chest pad.Connect right thigh pad.No improvement.Nurse was going to change out pads, leaving universal pad in place.Disabled manual mode.Nurse called back.They only had one set of medium in the closet, with the same lot ngkw1608.This set of pads also gave no flow, flow rate (fr) was 0lpm, inlet pressure (ip) was -0.2psi, circulation pump command (cpc) was 100%.This patient really needs a set of large pads.They were going to check with the er to see if they have another set of pads to try.Stated they would call back if not resolved.No further calls.Asked nurse to place pads behind the nursing station for quality to inspect.Per follow up information received via phone on 20feb2026, original complainant was not on current shift.Charge nurse confirmed pads were still at the desk and gave hospital address.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS
• Common Device Name: ARCTIC GEL PADS
• 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: 24464311
• Report Number: 1018233-2026-01316
• Device Sequence Number: 18475643
• Product Code: DWJ
• UDI-Device Identifier: 00801741080081
• UDI-Public: (01)00801741080081(17)270831(10)NGKW1608
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 05/26/2026

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: NGKW1608
• 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: 02/19/2026
• Supplement Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/07/2025
• 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