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

Catalog Number	50000000
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that they trying to initiate therapy on patient with new set of pads.Arctic sun device keeps alerting 02 low flow.Nurse stated they've already tried disconnecting and reconnecting with no resolution.Patient temperature (pt) was 38.3c, targeted temperature (tt) was 35c.Walked through stop therapy and disconnect pads.Placed device in manual control at 10c with no pads connected.System diagnostics: outlet monitor temperature (t1) was 10.2c, outlet control temperature (t2) was 10.2c, inlet temperature (t3) was 10.6c, chiller temperature (t4) was 4.6c, water flow rate (wfr) was 2.3 lm, inlet pressure (ip) was -7.8psi, circulation pump command (cpc) was 89 percent, mixing pump command (mpc) was 18 percent, heater command (hc) was 0, water reservoir level (wrl) was 5, system hours were 30800.8, pump hours were 12504.9.Reconnected pads while still in mc and water flow rate (wfr) was 0.8 lm, inlet pressure (ip) was -0.5psi.Disabled manual control and restarted therapy with pads connected.Water flow rate (wfr) was 0 lm and device low air leak.Advised swapping out to alternate device.Send this one to biomed labeled low flow.Sn (b)(6).Per follow up information received via phone on 11may2026, transferred to the biomed.Spoke with biomed who stated they'd like to discuss pm options for this device.No repairs made at this time.
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: 25185809
• Report Number: 1018233-2026-03170
• Device Sequence Number: 18804845
• Product Code: DWJ
• UDI-Device Identifier: 00801741080142
• UDI-Public: (01)00801741080142(11)121101
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/10/2026

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: 05/09/2026
• Supplement Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 05/15/2026
• Supplement Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2012
• 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