MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS; ARCTICGEL COOLING XXS KIT

Catalog Number	317-02
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
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: 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 when using normal temperature maintenance mode, low flow rate alarms occurred frequently in an arctic sun device.Connected only the confirmation line to the as5000 main unit and confirmed that there was no problem with the flow rate.When a 3s arctic gel pad was connected, it was confirmed that the constant flow rate was 1.0 l/min or less.Touching the tubing connected to the gel pad further reduced the flow rate.It was determined that the issue was caused by the pad.
Event or Problem Description
It was reported that when using normal temperature maintenance mode, low flow rate alarms occurred frequently in an arctic sun device.Connected only the confirmation line to the as5000 main unit and confirmed that there was no problem with the flow rate.When a 3s arctic gel pad was connected, it was confirmed that the constant flow rate was 1.0 l/min or less.Touching the tubing connected to the gel pad further reduced the flow rate.It was determined that the issue was caused by the pad.Per follow up information received via task on 03jun2025, sample will be sent to bd-approved facility for evaluation.A new gel pad was used, and treatment was completed.
Additional Manufacturer Narrative
The reported event is confirmed cause unknown as they changed the pads and flow rate issue is solved.Pfmea ra7600780 revision 22 was reviewed for this investigation.The reported event is addressed in step 24.The potential failure mode is "low flow/restricted due to overheating of materials during lamination process, water flow path compromised".Based on this review the risk is within the expected range.Current manufacturing controls in place to prevent this failure include: su-1090.Manufacturing procedure/inspection.Drawing.Leak test tm7600514 (100%).Visual aid vs6003o, vs6043o and vs6033o.Flow rate test tm7600515.Baw7667062 revision 0 was reviewed for this investigation.The labeling is found to be adequate.The baw is attached on the investigation overview element.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Correction: d.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.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS
• Common Device Name: ARCTICGEL COOLING XXS KIT
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 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: 22095658
• Report Number: 1018233-2025-03938
• Device Sequence Number: 6917236
• Product Code: DWJ
• UDI-Device Identifier: 00801741080029
• UDI-Public: (01)00801741080029(11)230210(17)250131(10)NGHN0895
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2025

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 Expiration Date: 01/31/2025
• Device Catalogue Number: 317-02
• Device Lot Number: NGHN0895
• 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: 05/22/2025
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2023
• 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