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

Catalog Number	317-07
Medical Device Problem Codes	Fluid/Blood Leak (1250); Gel Leak (1267)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the arctic gel pad leakage caused abnormal device operation, which was resolved by replacing it with a new gel pad.The issue was noticed at the moment of use.The affected product was used on a patient.No impact to the patient.
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.
Additional Manufacturer Narrative
The initial reporter's phone number: (b)(6).The reported issue was unconfirmed.The root cause of the reported issue could not be determined, as the returned sample met specifications during evaluation.Visual evaluation of the returned sample noted one opened medium arctic gel pad kit present with no original packaging.One photo sample was received for evaluation.Visual inspection noted the following: no obvious visible defects such as cuts or tears in the foam.No visible chips or deformities at the ends of all connectors.Tubing for all the pads noted no kinks present.Hydrogel was intact with pads and not separated.No crushed dimples or signs of overlamination in the pads.All pads were returned wet.The returned photo shows a right chest pad sticker with lot number ngjy4253.The reported issue could not be verified without further testing.Each pad was individually tested using tm0301222 rev 3.All individual measured flow rates are outlined.Right chest pad: a total of 6.2 l/min m2 of flow rate were registered during the test.Also, the system diagnostics were reviewed, and circulation pump command was 41%, inlet pressure was -7.0 psi.Left chest pad: a total of 6.7 l/min m2 of flow rate were registered during the test.Also, the system diagnostics were reviewed, and circulation ump command was 41%, inlet pressure was -7.1 psi.Right thigh pad: a total of 5.4 l/min m2 of flow rate were registered during the test.Also, the system diagnostics were reviewed, and circulation pump command was 30%, inlet pressure was -7.1 psi.Left thigh pad: a total of 4.6 l/min m2 of flow rate were registered during the test.Also, the system diagnostics were reviewed, and circulation pump command was 33%, inlet pressure was -7.2 psi.According to the test method tm0301222 rev 3 the flow rate was found to be acceptable for the returned pads.(acceptable range > 2.4 l/min.M2).No air leaks or water leaks were detected during flow testing.A risk review is not required as the reported event is unconfirmed.The labeling/packaging review is not required as the reported event is unconfirmed.A dhr review is not required as the reported event is unconfirmed.Based on the results of the investigation, no additional actions are needed.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.
Event or Problem Description
It was reported that the arctic gel pad leakage caused abnormal device operation, which was resolved by replacing it with a new gel pad.The issue was noticed at the moment of use.The affected product was used on a patient.No impact to the patient.Per follow up information received via task on 17sep2025, the sample has already been returned to the taipei office.

• 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: 23053512
• Report Number: 1018233-2025-08102
• Device Sequence Number: 15596592
• Product Code: DWJ
• UDI-Device Identifier: 00801741080081
• UDI-Public: (01)00801741080081(11)250107(17)261031(10)NGJY4253
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K142702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2025

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
• Device Lot Number: NGJY4253
• 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: 09/09/2025
• Supplement Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 11/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2025
• 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