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

Catalog Number	317-05
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2026
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 they were getting alarm 01 (patient line open) and alarm 02 (low flow) while trying to initiate therapy using arctic sun device.Flow rate was 0lpm, inlet pressure (ip) was -0psi, circulation pump command (cpc) was 0 percentage.Device reads priming.Pump hours were 2102.1, system hours were 2912.9.Stopped therapy, emptied and disconnected pads.Initiated manual control.Flow rate was 1.8lpm, inlet pressure (ip) was -7.1psi, circulation pump command (cpc) was 55 percentage.Connected right thigh pads.Inlet pressure (ip) was -4.4psi.Disconnected right thigh pad.Connected right chest pad.Inlet pressure (ip) was -1.9psi.Confirmed no visible damage to pads or fluid delivery line (fdl).Suggested replacing pads and putting this set behind the nursing station for return.Lot ngky3272.Per follow up information received via task on 07may2026, spoke with charge nurse who confirmed pad replacement was approved but was not attending this patient during the issue so they could not confirm if this action had been completed or if it resolved any issues.There were currently no patients on an arctic sun device.

• 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 CO 80027
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; +1(770)784-6100
• MDR Report Key: 25144099
• Report Number: 1018233-2026-03109
• Device Sequence Number: 9406816
• Product Code: DWJ
• UDI-Device Identifier: 00801741080067
• 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): 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: 317-05
• 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: 05/06/2026
• Supplement Date Received by Manufacturer: 07/22/2026
• Initial Report FDA Received Date: 05/11/2026
• 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