MAUDE Adverse Event Report: MEDIVANCE -1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, FLUID DELIVERY LINES

Catalog Number	734-07
Medical Device Problem Codes	Nonstandard Device (1420); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the biomed had an arctic sun device that was failing the fluid delivery line (fdl) valve test, the device has over 2000 hours and no history of the 2k pm.Coming in for 2k preventive maintenance.
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.
Additional Manufacturer Narrative
The reported issue was confirmed.The root cause of the reported issue is due to a failed o ring within one of the fdl valves.Internal flow was 1.4lpm, which is low.Three o rings were replaced.Device primed to fill during decon.Tank seals were worn or torn.The circulation pump outlet and mixing pump tubing were found to be dry rotting/experiencing material degradation.Pm performed.Tank seals were replaced.Circulation pump was serviced.The circulation pump outlet and mixing pump tubing were replaced.Serviced circulation pump and mixing pump.Replaced evaporator outlet tube, double bend tube, heater, drain valves, coin cell, and manifold o rings.The arctic sun passed functionality testing in compliance with manufacturer specifications, functions normally and is ready for use.The complaint or reported issue was confirmed through other elements of the investigation to not be labeling or packaging related.A dhr is not required because the batch number of the product is unknown.Based on the results of the investigation, no additional actions can be taken.Corrections: d, e, f, h.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.
Event or Problem Description
It was reported that the biomed had an arctic sun device that was failing the fluid delivery line (fdl) valve test, the device has over 2000 hours and no history of the 2k preventive maintenance.Coming in for 2k preventive maintenance.Per sample evaluation results received via task on 08dec2025, it was reported that the device primed to fill during decontamination.Tank seals were worn/torn.The circulation pump outlet and mixing pump tubing were found to be dry rotting/experiencing material degradation.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, FLUID DELIVERY LINES
• Common Device Name: FLUID DELIVERY LINES
• Manufacturer (Section D): MEDIVANCE -1725056; 321 south taylor ave; suite 200; louisville CO 80027
• Manufacturer (Section G): MEDIVANCE -1725056; 321 south taylor ave; suite 200; louisville CO 80027
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 23505260
• Report Number: 1018233-2025-10112
• Device Sequence Number: 12987742
• Product Code: DWJ
• UDI-Device Identifier: 00801741080265
• UDI-Public: (01)00801741080265
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 02/13/2026

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: 734-07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 11/08/2025
• Supplement Report FDA Received Date: 02/24/2026
• 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