MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® 5000; ARCTIC SUN DEVICE

Catalog Number	734-07
Medical Device Problem Codes	Gas/Air Leak (2946); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the nurse was trying to start therapy, but the arctic sun device was alerting patient line open.Sn#: (b)(6).Had nurse empty pads and disconnect (new small pads).Fluid delivery line (fdl) secure and in lock position.Reconnected holding nowhere near clear connectors and verified audible clicks with each connection.Straightened all lines.Restarted therapy.Water flow rate (wfr) got up to 0.6l/m then dropped back to 0 and device stopped.Confirmed alerts 01 & 02, system hours were 5465, pump hours were 4889.Placed device in manual control, inlet pressure (ip) was -1.0, circulation pump command (cpc) was 100 percentage mixing pump command (mpc) was 0, flow rate (fr) was 1.1l/m.Disabled manual control and had rn try one more time to start therapy.Inlet pressure (ip) was -0.6psi, circulation pump command (cpc) was 100 percentage, flow rate (fr) was 0 (fr jumped to 1.3 for only a minute and dropped back to 0).Explained this device needs to go to biomed.Confirmed they do not have another device and will have to find another source to warm the patient.Per follow up information received via phone on 14may2025, called operator, transferred to the biomed.Spoke with biomed who noted the fluid delivery line (fdl) had a small cut on one end.They had ordered a new one and replaced onsite.Device had returned to service.
Additional Manufacturer Narrative
The reported issue was confirmed.The root cause for the reported event was a small cut on one end of the fluid delivery line.Had nurse empty pads and disconnect (new small pads).Fluid delivery line (fdl) secure and in lock position.Reconnected holding nowhere near clear connectors and verified audible clicks with each connection.Straightened all lines.Restarted therapy.Water flow rate (wfr) got up to 0.6l/m then dropped back to 0 and device stopped.Confirmed alerts 01 & 02, system hours were 5465, pump hours were 4889.Placed device in manual control, inlet pressure (ip) was -1.0, circulation pump command (cpc) was 100 percentage mixing pump command (mpc) was 0, flow rate (fr) was 1.1l/m.Disabled manual control and had rn try one more time to start therapy.Inlet pressure (ip) was -0.6psi, circulation pump command (cpc) was 100 percentage, flow rate (fr) was 0 (fr jumped to 1.3 for only a minute and dropped back to 0).Explained this device needs to go to biomed.Confirmed they do not have another device and will have to find another source to warm the patient.Per follow up information received via phone on 14may2025, called operator, transferred to the biomed.Spoke with biomed who noted the fluid delivery line (fdl) had a small cut on one end.They had ordered a new one and replaced onsite.Device had returned to service.A dhr review is not required as the serial 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.Corrections: b, f, h.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 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 was trying to start therapy, but the arctic sun device was alerting patient line open.Sn #(b)(6).Had nurse empty pads and disconnect (new small pads).Fluid delivery line (fdl) secure and in lock position.Reconnected holding nowhere near clear connectors and verified audible clicks with each connection.Straightened all lines.Restarted therapy.Water flow rate (wfr) got up to 0.6l/m then dropped back to 0 and device stopped.Confirmed alerts 01 & 02, system hours were 5465, pump hours were 4889.Placed device in manual control, inlet pressure (ip) was -1.0, circulation pump command (cpc) was 100 percentage mixing pump command (mpc) was 0, flow rate (fr) was 1.1l/m.Disabled manual control and had rn try one more time to start therapy.Inlet pressure (ip) was -0.6psi, circulation pump command (cpc) was 100 percentage, flow rate (fr) was 0 (fr jumped to 1.3 for only a minute and dropped back to 0).Explained this device needs to go to biomed.Confirmed they do not have another device and will have to find another source to warm the patient.

• Brand Name: ARCTIC SUN® 5000
• 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 CO 80027
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 21730667
• Report Number: 1018233-2025-02135
• Device Sequence Number: 18392872
• Product Code: DWJ
• UDI-Device Identifier: 00801741080265
• UDI-Public: (01)00801741080265
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/23/2025

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: 03/26/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 07/24/2025
• 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