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	04/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported issue was confirmed.The root cause of the reported issue is due to a failed circulation pump.Installed test circulation pump to filled and continued the process.Circulation pump with new motor was replaced during the pm.Pm performed.Replace mixing pump head, the heater, the drain valves and both manifold o-rings on the manifold.Replaced coin cell due to age.The device was placed on (ctu calibration and test system).An electrical safety test was performed.A final inspection was performed.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.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 nurses sent the arctic sun device due to pads not filling, biomed was not sure if they were having any other issues such as low flow.Per follow up information received via task on 14apr2026, spoke with biomed who stated they had already spoken with technical support regarding this issue.They denied any issues with detecting water level, but the device was having issues with the water flow rate level.The device will be repaired by bd.

• 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: 25641983
• Report Number: 1018233-2026-04152
• Device Sequence Number: 13143242
• Product Code: DWJ
• UDI-Device Identifier: 00801741127755
• UDI-Public: (01)00801741127755
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 06/23/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2026
• Initial Report FDA Received Date: 06/26/2026
• 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