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

Catalog Number	734-07
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that they were getting a patient line open message on arctic sun device s/n (b)(6).Flow rate (fr) was 0lpm, inlet pressure (ip) was -0.6psi, circulation pump command (cpc) was 100%, pump hours were 3016.5, system hours were 3174.8.Stopped therapy.Emptied and disconnected the pads.Placed device in manual mode.Inlet pressure (ip) remained around -2psi.Advised to send device to biomed and change to another device.On a follow-up call nurse stated they could see a hole in the fluid delivery line.It was reported that they changed to arctic sun device s/n (b)(6), but now they were having a different problem.The device will not fill.Water level with one bar.Fluid deliver line attached with nothing attached to fluid delivery line.Had nurse remove the fluid delivery line and plug the ports on the back of the machine to see if they could feel suction.Reservoir filled when she plugged the ports.Connected pads and tried to start therapy.Flow rate was 0lpm, inlet pressure was -0psi, circulation pump command was 100%.Pump hours 5071.5, system hours 5317.2.Stopped therapy.Disconnected pads and started manual mode.Inlet pressure and flow remained at 0.Explained it seems to be a problem with the fluid delivery line.Suggested getting the fdl from the first device ((b)(6)) but stated they could see a visible hole in the fdl.They could not see visible damage on the fdl connected to (b)(6).Suggested obtaining another fdl or device.They asked about changing the pads.Advised against it.
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 inconclusive.The root cause for the reported event could not be determined.It was reported that they changed to arctic sun device s/n (b)(6), but now they were having a different problem.The device will not fill.Water level with one bar.Fluid deliver line attached with nothing attached to fluid delivery line.Had nurse remove the fluid delivery line and plug the ports on the back of the machine to see if they could feel suction.Reservoir filled when she plugged the ports.Connected pads and tried to start therapy.Flow rate was 0lpm, inlet pressure was -0psi, circulation pump command was 100%.Pump hours 5071.5, system hours 5317.2.Stopped therapy.Disconnected pads and started manual mode.Inlet pressure and flow remained at 0.Explained it seems to be a problem with the fluid delivery line.Suggested getting the fdl from the first device ((b)(6)) but stated they could see a visible hole in the fdl.They could not see visible damage on the fdl connected to (b)(6).Suggested obtaining another fdl or device.They asked about changing the pads.Advised against it.A dhr review is not required as the lot number is unknown.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.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 they were getting a patient line open message on arctic sun device s/n (b)(6).Flow rate (fr) was 0lpm, inlet pressure (ip) was -0.6psi, circulation pump command (cpc) was 100%, pump hours were 3016.5, system hours were 3174.8.Stopped therapy.Emptied and disconnected the pads.Placed device in manual mode.Inlet pressure (ip) remained around -2psi.Advised to send device to biomed and change to another device.On a follow-up call nurse stated they could see a hole in the fluid delivery line.It was reported that they changed to arctic sun device s/n (b)(6), but now they were having a different problem.The device will not fill.Water level with one bar.Fluid deliver line attached with nothing attached to fluid delivery line.Had nurse remove the fluid delivery line and plug the ports on the back of the machine to see if they could feel suction.Reservoir filled when she plugged the ports.Connected pads and tried to start therapy.Flow rate was 0lpm, inlet pressure was -0psi, circulation pump command was 100%.Pump hours 5071.5, system hours 5317.2.Stopped therapy.Disconnected pads and started manual mode.Inlet pressure and flow remained at 0.Explained it seems to be a problem with the fluid delivery line.Suggested getting the fdl from the first device ((b)(6)) but stated they could see a visible hole in the fdl.They could not see visible damage on the fdl connected to (b)(6).Suggested obtaining another fdl or device.They asked about changing the pads.Advised against it.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, FLUID DELIVERY LINES
• Common Device Name: FLUID DELIVERY LINES
• 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: 23404101
• Report Number: 1018233-2025-09653
• Device Sequence Number: 4927732
• Product Code: DWJ
• UDI-Device Identifier: 00801741080265
• UDI-Public: (01)00801741080265
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 11/20/2025

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: 10/21/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 12/02/2025
• 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