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	11/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that they were trying to initiate therapy using arctic sun device s/n (b)(6) but were getting a low flow alertalert 02).Flow rate (fr) was 0lpm, inlet pressure (ip) was -0.2psi, circulation pump command (cpc) was 100%, system hours 885.5, pump hours 705.2.Had nurse stop therapy, disconnect and reconnect the pads, and resume therapy.No improvement.Stopped therapy, emptied and disconnected the pads.Started manual mode.1.8lpm, -7.0spi, 51%.Connected the right thigh pad.0.5lpm, -0.3psi, 100%.Disconnected right thigh pad and connected other pads one at a time.Right chest 1.2lpm, -6.9lpm, 96%.Left chest 1.5lpm, -7.1psi, 46%.Left thigh 2.4lpm, -7.2psi, 68%.Reconnected right thigh pad and flow and inlet pressure (ip) was dropped again, 0.1lpm, -0.6psi.Removed right thigh pad.Patient also has a universal pad in place.Connected universal pad.3.4lpm, -7.2psi, 83%.Lot ngkq1967.Asked nurse to put damaged pad behind the nurse's station.Suggested replacing right thigh pad with a universal pad, but they do not have any left.They will open another set of pads.Disabled manual mode and started therapy.Flow rate was 3.3lpm.
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.
Additional Manufacturer Narrative
The reported event is confirmed cause unknown as they replaced the pads and flow rate issue is solved.Sample was not available for evaluation.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.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 were trying to initiate therapy using arctic sun device s/n (b)(6) but were getting a low flow alertalert 02).Flow rate (fr) was 0lpm, inlet pressure (ip) was -0.2psi, circulation pump command (cpc) was 100%, system hours 885.5, pump hours 705.2.Had nurse stop therapy, disconnect and reconnect the pads, and resume therapy.No improvement.Stopped therapy, emptied and disconnected the pads.Started manual mode.1.8lpm, -7.0spi, 51%.Connected the right thigh pad.0.5lpm, -0.3psi, 100%.Disconnected right thigh pad and connected other pads one at a time.Right chest 1.2lpm, -6.9lpm, 96%.Left chest 1.5lpm, -7.1psi, 46%.Left thigh 2.4lpm, -7.2psi, 68%.Reconnected right thigh pad and flow and inlet pressure (ip) was dropped again, 0.1lpm, -0.6psi.Removed right thigh pad.Patient also has a universal pad in place.Connected universal pad.3.4lpm, -7.2psi, 83%.Lot ngkq1967.Asked nurse to put damaged pad behind the nurse's station.Suggested replacing right thigh pad with a universal pad, but they do not have any left.They will open another set of pads.Disabled manual mode and started therapy.Flow rate was 3.3lpm.Per follow up information received via phone on 24nov2025, transferred to nurse specialist and educator who noted after therapy completed, they collected the remaining pads from the set and placed them with the faulty thigh pad just in case there was a fault with the entire set.They inspected the thigh pad and did not see any obvious defects with the pad or connectors.This pad set was collected by the representative over the weekend.

• 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: 23633399
• Report Number: 1018233-2025-10502
• Device Sequence Number: 9337230
• Product Code: DWJ
• UDI-Device Identifier: 00801741080029
• UDI-Public: (01)00801741080029(11)250429(17)270228(10)NGKQ1967
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 04/10/2026

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: NGKQ1967
• 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: 11/15/2025
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 04/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2025
• 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