MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, FILL TUBE; ARCTIC SUN DEVICE

Catalog Number	71800
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported issue was confirmed.The arctic sun 5000 was evaluated upon receipt.During the evaluation it was found that the fill tube was brittle.(arctic sun 5000) no error code observed.Fill tube was replaced.The as5000 system was evaluated for functionality and results were recorded.An electrical safety test was performed; as5000 system passed all tests, is functioning properly and is ready for use.A dhr review is not required as the lot number is unknown.The lot number for this investigation is unknown.Corrections made to tab(s) d, h.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 the per wo evaluation, there was a faulty mixing pump, faulty circulation pump and filling tube was brittle in an arctic sun device.Per sample evaluation results received via task on 05mar2026, it was reported that the coin cell needing to be replaced.
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 the per wo evaluation, there was a faulty mixing pump, faulty circulation pump and filling tube was brittle in an arctic sun device.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, FILL TUBE
• Common Device Name: ARCTIC SUN DEVICE
• 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: 24531377
• Report Number: 1018233-2026-01538
• Device Sequence Number: 16045330
• Product Code: DWJ
• UDI-Device Identifier: 00801741080197
• UDI-Public: (01)00801741080197
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K161602
• 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): 03/09/2026

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: 71800
• 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: 03/02/2026
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown