MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® 5000; ARCTIC SUN DEVICE

Catalog Number	50000000E
Medical Device Problem Code	Failure to Pump (1502)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned.Reported issue: it was reported that the arctic sun device was showing -5.5-6.2 psi.Reported issue root cause: the root cause for the reported event is a weak circulation pump.Repairs related to the reported issue: per additional information received via ttm on 28may2026, biomed was doing preventive maintenance procedure.Checking fluid delivery line (fdl) and inlet pressure (ip) was registering at -5.5 to -6.7psi.Conclusion: the reported issue was confirmed.The root cause for the reported event is a weak circulation pump.Per additional information received via ttm on 28may2026, biomed was doing preventive maintenance procedure.Checking fluid delivery line (fdl) and inlet pressure (ip) was registering at -5.5 to -6.7psi.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.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 arctic sun device was showing -5.5-6.2.Per additional information received via ttm on 28may2026, biomed was doing preventive maintenance procedure.Checking fluid delivery line (fdl) and inlet pressure (ip) was registering at -5.5 to -6.7psi.

• Brand Name: ARCTIC SUN® 5000
• Common Device Name: ARCTIC SUN DEVICE
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer (Section G): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 25540994
• Report Number: 1018233-2026-03969
• Device Sequence Number: 9634232
• Product Code: DWJ
• UDI-Device Identifier: 00801741127755
• UDI-Public: (01)00801741127755
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Report Date (Section B): 06/16/2026

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: 50000000E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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