MAUDE Adverse Event Report: MEDIVANCE -1725056 ARCTIC SUN® 5000; ARCTIC SUN DEVICE

Catalog Number	50000000L
Medical Device Problem Codes	Failure to Pump (1502); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the biomed called and stated that the nurse had reported a 113 alert in an arctic sun device and they brought the unit down to biomed and turned it on and it was leaking from the bottom.Per additional information update from ttm on 06jun2025, biomed had loaner device leaking from the bottom.Per review of wo, recommended to drain the unit and refill, it was possible the nurse overfilled the unit.
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 issue was confirmed.The root cause of the reported issue was isolated to a faulty mixing pump.The arctic sun 5000 was evaluated upon receipt.During the evaluation it was found that mixing pump.Case data confirms 113 alerts.Mixing pump was serviced.Leak on chiller pump o-rings was observed.Unit is scheduled for 2k pm.Chiller pump o-rings were replaced.Circulation pump was serviced.Heater, drain valves, manifold o-rings, tank tubing and coin cell battery were replaced.The arctic sun 5000 passed all performance testing, calibration, and electrical safety tests.The unit is ready for use.In the event that information regarding the outcome of the repair and the status of the device is received, this record will be reopened to update the investigation.See the attached investigation closure memo for more information.The complaint or reported issue was confirmed through other elements of the investigation to not be labeling or packaging related.A dhr is not required as the device has undergone previous servicing and therefore the reported issue is not manufacturing related.No additional actions can be taken at this time.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 biomed called and stated that the nurse had reported a 113 alert in an arctic sun device and they brought the unit down to biomed and turned it on and it was leaking from the bottom.Per additional information update from ttm on 06jun2025, biomed had loaner device leaking from the bottom.Per review of work order, recommended to drain the unit and refill, it was possible the nurse overfilled the unit.

• Brand Name: ARCTIC SUN® 5000
• Common Device Name: ARCTIC SUN DEVICE
• Manufacturer (Section D): MEDIVANCE -1725056; 321 south taylor ave; suite 200; louisville CO 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: 22187514
• Report Number: 1018233-2025-04447
• Device Sequence Number: 12908550
• Product Code: DWJ
• UDI-Device Identifier: 00801741080159
• UDI-Public: (01)00801741080159(11)161003
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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): 10/21/2025

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: 50000000L
• 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: 06/06/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2016
• 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