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

Catalog Number	50000000L
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	11/07/2025
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.All available udi information is being provided.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 per wo evaluation, arctic sun device was reading full when it was empty, installed test io card.There was no suction, installed test circulation pump to fill.
Event or Problem Description
It was reported that per wo evaluation, arctic sun device was reading full when it was empty, installed test io card.There was no suction, installed test circulation pump to fill.Per sample evaluation results on 26nov2025, plastic shell shavings and foam found within the unit.Level sensor cup cracked.Level sensor tubing expanded.Flow meter showed evidence of sticking.The servicers noted that the shell pieces were found within the unit while the foam was found within the tank.
Additional Manufacturer Narrative
The initial reporter's zip code: (b)(6).The reported issue was confirmed.The root cause of the reported issue is a failed circulation pump.The device was evaluated upon receipt.There was no suction in decontamination, installed test circulation pump to fill.Serviced circulation pump.An electrical safety test and ctu calibration were performed and passed.The arctic sun passed functionality testing in compliance with manufacturer specifications, functions normally and is ready for use.The complaint or reported issue was confirmed through other elements of the investigation to not be labeling or packaging related.A dhr review is not required as the reported event is not an out of box failure and therefore the reported event is not manufacturing related.Based on the results of the investigation, no additional actions are needed.Corrections: d, e, 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.

• 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: 23541938
• Report Number: 1018233-2025-10220
• Device Sequence Number: 9775458
• Product Code: DWJ
• UDI-Device Identifier: 00801741080159
• UDI-Public: (01)00801741080159(11)150201
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 11/26/2025

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 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: 11/07/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2015
• 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