MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN STAT; ARCTIC SUN DEVICE

Catalog Number	60000000L
Medical Device Problem Codes	Insufficient Cooling (1130); Failure to Pump (1502)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the in wo evaluation, the arctic sun device would not cool unless the mixing pump was at 100 percentage power.
Additional Manufacturer Narrative
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 issue was confirmed.The root cause of the reported issue is due to a failed mixing pump.During evaluation, it was confirmed that the mixing pump was not at 100% power and did not function to specifications.Mixing pump was serviced.The arctic sun 6000 passed all performance testing, calibration and electrical safety tests and is functioning properly and ready for use.A review of the risk document, ra2800028 rev 16, was reviewed for this investigation.The risk documentation was addressed in step # d445.This occurrence does not introduce a new hazard or harm.It represents a known failure mode that has been assessed in the product risk management file in accordance with applicable regulatory standards and internal procedures.The associated risks continue to be monitored as part of ongoing post-market activities in compliance with both regulatory requirements and local procedures.The complaint or reported issue was confirmed through other elements of the investigation to not be labeling or packaging related.The complaint or reported issue was confirmed through other elements of the investigation to not be manufacturing related.Correction: d, f, 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 in wo evaluation, the arctic sun device would not cool unless the mixing pump was at 100 percentage power.

• Brand Name: ARCTIC SUN STAT
• Common Device Name: ARCTIC SUN DEVICE
• 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: 22532678
• Report Number: 1018233-2025-05942
• Device Sequence Number: 7472935
• Product Code: DWJ
• UDI-Device Identifier: 00801741161520
• UDI-Public: (01)00801741161520(11)210522
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K200225
• 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): 09/05/2025

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: 60000000L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Supplement Date Received by Manufacturer: 09/05/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2021
• 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