MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 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	12/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the biomed stated that the arctic sun device had a low pressure during the inspection of the fluid delivery line.Per review of wo notes it was determined that the fluid delivery line (fdl) will need new valves for one set.Circulation pump command (cpc) was 48%, inlet pressure (ip) was -7.0, flow rate (fr) was 1.8.
Additional Manufacturer Narrative
The initial reporter's zip code: (b)(6).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 identified as air leaks in fluid delivery line.Per review of wo notes it was determined that the fluid delivery line (fdl) will need new valves for one set.Circulation pump command (cpc) was 48 percent, inlet pressure (ip) was -7.0, flow rate (fr) was 1.8.The complaint or reported issue was confirmed through other elements of the investigation to not be labeling or packaging related.A dhr review is not required as the serial number is unknown.No additional actions are needed.Correction: 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 stated that the arctic sun device had a low pressure during the inspection of the fluid delivery line.Per review of wo notes it was determined that the fluid delivery line (fdl) will need new valves for one set.Circulation pump command (cpc) was 48%, inlet pressure (ip) was -7.0, flow rate (fr) was 1.8.
Additional Manufacturer Narrative
The reported issue was confirmed.The root cause identified as air leaks in fluid delivery line.Per review of wo notes it was determined that the fluid delivery line (fdl) will need new valves for one set.Circulation pump command (cpc) was 48 percent, inlet pressure (ip) was -7.0, flow rate (fr) was 1.8.The complaint or reported issue was confirmed through other elements of the investigation to not be labeling or packaging related.A dhr review is not required as the serial number is unknown.Correction: f, g, h.Complete initial reporter zip: (b)(6).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 stated that the arctic sun device had a low pressure during the inspection of the fluid delivery line.Per review of wo notes it was determined that the fluid delivery line (fdl) will need new valves for one set.Circulation pump command (cpc) was 48%, inlet pressure (ip) was -7.0, flow rate (fr) was 1.8.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, FLUID DELIVERY LINES
• Common Device Name: FLUID DELIVERY LINE
• 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: 23779765
• Report Number: 1018233-2025-11054
• Device Sequence Number: 13280868
• Product Code: DWJ
• UDI-Device Identifier: 00801741080265
• UDI-Public: (01)00801741080265
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,Followup
• Report Date (Section B): 02/25/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 02/11/2026; 02/25/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 02/24/2026; 03/02/2026
• 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