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

Catalog Number	50000000
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that before software update, at flow rate test, the value was out of allowance negative 392 ml min in an arctic sun device.Per review of wo on 06feb2026, there was no patient involvement.
Additional Manufacturer Narrative
The initial reporter's phone number: (b)(6).The reported issue was confirmed.The root cause of the reported issue was isolated to a faulty flow meter.The arctic sun 5000 was evaluated upon receipt.During the evaluation it was found that the flow meter had failed.(arctic sun 5000) no error code observed.Flowmeter replacement and functional check were performed.Unit was evaluated for functionality.Arctic sun passed all tests successfully and unit is ready to be back in service.The outcome of the repair cannot be determined at this time.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.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: 25196025
• Report Number: 1018233-2026-03195
• Device Sequence Number: 13364392
• Product Code: DWJ
• UDI-Device Identifier: 00801741080142
• UDI-Public: (01)00801741080142
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 05/13/2026

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: 50000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 05/16/2026
• 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