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

Catalog Number	317-09-02
Medical Device Problem Codes	Inaccurate Flow Rate (1249); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the nurse stated they had been trying to initiate ttm and had tried all of the troubleshooting steps for the flow rate alert02) but had been unsuccessful.Flow rate (fr) was 0.5lpm.Guided to system diagnostics, system hours 8679, pump hours 7929, inlet pressure (ip) was -2.6psi, circulation pump command (cpc) was100%.Disconnected and reconnected pads using proper technique.No change in values.Therapy has been ongoing for about 36 hours.Explained one or more of the pads could have been damaged and they can test each pad individually and try to determine which one/ones need to be replaced.They opted to change the whole set of pads.Advised product complaints may follow up with (970) 624-2100 regarding getting the pads back for investigation.Pad lot number ngju3967.No further calls from this account.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.All available udi information is being provided.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 nurse stated they had been trying to initiate ttm and had tried all of the troubleshooting steps for the flow rate alert02) but had been unsuccessful.Flow rate (fr) was 0.5lpm.Guided to system diagnostics, system hours 8679, pump hours 7929, inlet pressure (ip) was -2.6psi, circulation pump command (cpc) was100 percent.Disconnected and reconnected pads using proper technique.No change in values.Therapy has been ongoing for about 36 hours.Explained one or more of the pads could have been damaged and they can test each pad individually and try to determine which one/ones need to be replaced.They opted to change the whole set of pads.Advised product complaints may follow up regarding getting the pads back for investigation.Pad lot number ngju3967.No further calls from this account.
Additional Manufacturer Narrative
The reported event was confirmed.The root cause of the reported issue is that the connectors are damaged.Visual evaluation of the returned sample noted one opened large arctic gel pad kit present with no original packaging.Visual inspection noted the following: no obvious visible defects such as cuts or tears in the foam.All connectors are deformed.Tubing for all the pads noted no major kinks present.Hydrogel was intact with pad and not separated.No crushed dimples or signs of overlamination in the pads.The edge of the right thigh pad is cut very close to the flow path.Misalignment of the pad cut is also seen on the left chest pad.The reported issue could not be verified without further testing.The reported event is addressed within the labeling as it states, 5.Attach the pad¿s line connectors to the patient line manifolds.Begin circulating water through the pads using either patient temperature control mode (automatic) or water temperature control mode (manual).If the pads fail to prime or a significant continuous air leak is observed in the pad return line, check connections, then if needed replace the leaking pad.6.Once the pads are primed, assure the flow rate displayed on the control panel is greater than 1.7 liters per minute, which is the minimum flow rate for a full pad kit (4).A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.No additional actions can be taken at this time.Corrections: d, f, h.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.

• 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 ; 7707846100
• MDR Report Key: 23268598
• Report Number: 1018233-2025-09039
• Device Sequence Number: 10180204
• Product Code: DWJ
• UDI-Device Identifier: 00801741080104
• UDI-Public: (01)00801741080104(11)240911(17)260630(10)NGJU3967
• 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): 03/04/2026

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 Expiration Date: 06/30/2026
• Device Catalogue Number: 317-09-02
• Device Lot Number: NGJU3967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2025
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 10/10/2025
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2024
• 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