MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, FLUID DELIVERY LINES; ARCTIC SUN FLUID DELIVERY LINE

Catalog Number	734-07
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the biomed did preventive maintenance check on their arctic sun device.When they checked each valve on the fluid delivery line (fdl), only one was within specification with a psi of -7.The other valves are giving a psi of about -5.
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.
Additional Manufacturer Narrative
The reported issue was confirmed.Root cause was not able to be isolated as unit was not evaluated.A review of the risk document, ra2800010 rev 24, was performed for this investigation.The reported event is addressed in step # ra110.Based on this review the risk is within the expected range.The serial number for this investigation is unknown.The latest labeling revision will be reviewed for this investigation.The instructions-for-use under baw2800548 rev 3 and baw2800424 rev 2 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 review is not required as the serial number is unknown.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 biomed did preventive maintenance check on their arctic sun device.When they checked each valve on the fluid delivery line (fdl), only one was within specification with a psi of -7.The other valves are giving a psi of about -5.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, FLUID DELIVERY LINES
• Common Device Name: ARCTIC SUN FLUID DELIVERY LINE
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 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: 21223146
• Report Number: 1018233-2025-00285
• Device Sequence Number: 19693323
• Product Code: DWJ
• UDI-Device Identifier: 00801741080265
• UDI-Public: (01)00801741080265
• 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): 06/13/2025

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: 01/16/2025
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 06/17/2025
• 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