MAUDE Adverse Event Report: MEDIVANCE -1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS; ARCTICGEL 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	03/10/2026
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 arctic sun device was giving low flow.Already spoke with rep and tried basic troubleshooting with pads.Normothermia adult patient 4 pads connected size large.Water flow rate (wfr) was 1.2 l/m.Normothermia patient temperature (pt) was 38.4c, targeted temperature (tt) was 36c, water temperature (wt) was 5.4c, water flow rate (wfr) was 1.2 l/m.Walked through stop therapy, empty and disconnect pads.Placed in manual control at 4c with no pads.System diagnostics: outlet monitor temperature (t1) was 5.3c, outlet control temperature (t2) was 5.3c, inlet temperature (t3) was 6.5c, chiller temperature (t4) was 4.7c, water flow rate (wfr) was 1.1 l/m, inlet pressure (ip) was -7psi, circulation pump command (cpc) was 37%, mixing pump command (mpc) was 100%, heater command (hc) was 0, water reservoir level (wrl) was 5, system hours were 3718, pump hours were 3067.Added back pads while in mc and water flow rate (wfr) was 2.4 l/m.Disabled manual control water flow rate (wfr) was 1.1 l/m.Sn: (b)(6) swap out pads.Per follow up information received via phone on 11mar2026, spoke with nurse who stated they had tried changing the device first since they already had one available on the unit.The flow rate remained the same around 1.0-1.1 lpm.They decided to add an additional universal pad to the patient because there was a small amount of exposed skin.This raised the flow rate to around 2.0 lpm.Patient was still continuing therapy at this time.They will make a note to retain the pads at end of treatment.No further information available.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS
• Common Device Name: ARCTICGEL 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 ; 7707846100
• MDR Report Key: 24594584
• Report Number: 1018233-2026-01718
• Device Sequence Number: 21413946
• Product Code: DWJ
• UDI-Device Identifier: 00801741080104
• UDI-Public: (01)00801741080104
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 05/21/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Supplement Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 06/03/2026
• 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