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

Catalog Number	50000000
Medical Device Problem Codes	Insufficient Cooling (1130); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2026
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.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 they were trying to deliver therapy using s/n (b)(6), but the arctic sun device was stopping, giving alert 113 (reduced water temperature control) (pr# (b)(6)).Targeted temperature (tt) was 36c, patient temperature (pt) was 36.1c, flow rate (fr) was 3.2lpm, water temperature (wt) was 31.5c, chiller temperature (t4) was 3.8c, mixing pump command (mpc) was 100%, system hours 11000, pump hours 10063.Explained device needs to go to biomed labeled with alert 113, not cooling.They initially tried to use s/n (b)(6) but was getting low air leak.Powered s/n (b)(6) back on and pressed continue current patient.Enabled manual mode.Flow rate (fr) was 1.7lpm, inlet pressure (ip) was -7.0psi, circulation pump command (cpc) was 62%, pump hours were 3487, system hours 3883.Connected pads using proper technique (pr# (b)(6)).Flow rate (fr) was 3.2lpm, inlet pressure (ip) was -7.3psi, circulation pump command (cpc) was 97%.Disabled manual mode and started therapy.Flow rate (fr) was 3lpm, inlet pressure (ip) was -7psi, circulation pump command (cpc) was 91%.Therapy continued.Per follow up information received via phone on (b)(6) 2026, spoke with nurse who confirmed no further issues after reconnecting the pads with the helpline.They were unsure the exact size of the pads, aside from they were adult sized and there were 4 in use.Therapy had completed and pads were disposed of.Per additional information received from biomed via tech support under (b)(4) on (b)(6) 2026, they stated that the device was not cooling and failing calibration for error 80.Expected 6, actual 29.T4 was reading 35c.Verified the water level in the chiller tank.They discussed that this was indicative of a chiller failure.

• 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: 25060285
• Report Number: 1018233-2026-02745
• Device Sequence Number: 21170582
• Product Code: DWJ
• UDI-Device Identifier: 00801741080142
• UDI-Public: (01)00801741080142(11)260601
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 06/09/2026

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: 04/21/2026
• Supplement Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 05/01/2026
• Supplement Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2011
• 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