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

Catalog Number	60000000L
Medical Device Problem Code	Insufficient Cooling (1130)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2025
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 the nurse stated that arctic sun device alerted 113 reduced water temperature control while trying to cool patient.Patient temperature (pt) was 38.4c, targeted temperature (tt) was 36c, water temperature (wt) was 7.2c, water flow rate (wfr) was 2.7 l/m.System diagnostics showed that the outlet monitor temperature (t1) was 7.1c, outlet control temperature (t2) was 7.1c, inlet temperature (t3) was 8.2c, chiller temperature (t4) was 3.8c, water flow rate (wfr) was 2.7 l/m, inlet pressure (ip) was -7.0 psi, circulation pump command (cpc) was 70 percentage, mixing pump command (mpc) was 100 percentage, heater was 0, water reservoir level (wrl) was 4, system hours were 1485.4 and pump hours were 8.0.Advised to send to biomed labeled 113 (reduced water temperature control) not cooling.
Additional Manufacturer Narrative
The reported issue was confirmed.At this time, the root cause of the reported event could not be determined.The instructions-for-use are found to be adequate.The ifu currently instructs the user on the proper method to use this device to avoid undue injury to the patient and damage to the product.A dhr is not required as the device has undergone previous servicing and therefore the reported issue is not manufacturing related.No additional actions can be taken at this time.Correction: d.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 nurse stated that arctic sun device alerted 113 reduced water temperature control while trying to cool patient.Patient temperature (pt) was 38.4c, targeted temperature (tt) was 36c, water temperature (wt) was 7.2c, water flow rate (wfr) was 2.7 l/m.System diagnostics showed that the outlet monitor temperature (t1) was 7.1c, outlet control temperature (t2) was 7.1c, inlet temperature (t3) was 8.2c, chiller temperature (t4) was 3.8c, water flow rate (wfr) was 2.7 l/m, inlet pressure (ip) was -7.0 psi, circulation pump command (cpc) was 70 percentage, mixing pump command (mpc) was 100 percentage, heater was 0, water reservoir level (wrl) was 4, system hours were 1485.4 and pump hours were 8.0.Advised to send to biomed labeled 113 (reduced water temperature control) not cooling.Per follow up information received via task on 02oct2025, spoke with biomed who confirmed this device was on the unit, but unrepaired.They were working on sending this loaner unit back and exchange for another working one.They were waiting on a shipping pallet at this time.

• Brand Name: ARCTIC SUN STAT
• 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: 23123368
• Report Number: 1018233-2025-08474
• Device Sequence Number: 13092784
• Product Code: DWJ
• UDI-Device Identifier: 00801741161520
• UDI-Public: (01)00801741161520(11)210419
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K200225
• 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): 01/21/2026

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: 60000000L
• 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: 09/17/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 09/23/2025
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2021
• 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