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

Catalog Number	60000000L
Medical Device Problem Codes	Restricted Flow rate (1248); Failure to Pump (1502)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
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 the customer stated that the arctic sun device display was damaged while at their site.Updated wo to show complaint.Per sample evaluation results on (b)(6) 2025, it was reported that the device was not filling (circulation pump issue).It was reported that the pressure reading was -6.0psi with no pumps running (pressure transducer failure).
Additional Manufacturer Narrative
The reported event was confirmed.The root cause for the reported event is a failed circulation pump.The device was evaluated upon receipt.During evaluation it was found that the device would not fill.Completed the 2000-hour pm procedure on the device.This included the servicing of circulation pump and mixing pump, replacing heater, replacing both manifold o-rings, replacing the drain valves, and replacement of the double bend tube and the chiller evaporator outlet tube.The coin cell in the refurbished control panel was replaced due to age.The arctic sun 6000 passed all performance testing, calibration and electrical safety tests and is functioning properly and ready for use.The complaint or reported issue was confirmed through other elements of the investigation to not be manufacturing related.The complaint or reported issue was confirmed through other elements of the investigation to not be labeling or packaging related.Corrections: d, f, h.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 the customer stated that the arctic sun device display was damaged while at their site.Updated wo to show complaint.Per sample evaluation results on 20jan2025, it was reported that the device was not filling (circulation pump issue).It was reported that the pressure reading was -6.0psi with no pumps running (pressure transducer failure).

• Brand Name: ARCTIC SUN STAT
• Common Device Name: ARCTIC SUN DEVICE
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville CO 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 ; 7707846100
• MDR Report Key: 24223867
• Report Number: 1018233-2026-00472
• Device Sequence Number: 9366959
• Product Code: DWJ
• UDI-Device Identifier: 00801741161520
• UDI-Public: (01)00801741161520(11)201221
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 02/13/2026

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: 60000000L
• 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: 01/20/2026
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2020
• 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