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

Catalog Number	50000000
Medical Device Problem Codes	Insufficient Cooling (1130); Failure to Pump (1502)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the left message with desk for nurse to call back at since they could not come to the phone.Nurse noted they have received multiple alerts, and the arctic sun device did not seem to be regulating the patient temperature (pt).Event log shows multiple alert 113 reduced water temperature control.Patient temperature (pt) was 34.3c, targeted temperature (tt) was 33.5c, water temperature (wt) was 26.9c, water flow rate (wfr) was 1.2 l per m.System diagnostics showed that the outlet monitor temperature (t1) was 27c, outlet control temperature (t2) was 26.9c, inlet temperature (t3) was 26.8c, chiller temperature (t4) was 4.3c, water flow rate (wfr) was 1.2 l per m, inlet pressure (ip) was -7psi, circulation pump command (cpc) was 49 percentage, mixing pump command (mpc) was 100 percentage, heater was 0, water reservoir level (wrl) was 5, system hours were 3730.4 and pump hours were 3148.5.Advised swapping out to alternate device and sending this one to biomed labeled 113 not cooling.Per follow up information received via phone on 28apr2026, spoke with biomed who confirmed a faulty mixing pump.They would be ordering one this week to repair onsite.No further information available.
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: 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, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville CO 80027
• Manufacturer (Section G): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville CO 80027
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 25045486
• Report Number: 1018233-2026-02791
• Device Sequence Number: 9725779
• Product Code: DWJ
• UDI-Device Identifier: 00801741080142
• UDI-Public: (01)00801741080142(11)150401
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 05/07/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2026
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 04/30/2026
• Supplement Report FDA Received Date: 05/15/2026
• 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