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

Catalog Number	734-07
Medical Device Problem Codes	Restricted Flow rate (1248); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
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 recently began therapy and the arctic sun device now alerting patient line open and low flow.Nurse states had already disconnected and reconnected pads into different manifolds and confirmed connections.Targeted temperature (tt) was 36c, patient temperature (pt) was 36.7c, water temperature (wt) was 8.5c, water flow rate (wfr) was 0 l/m.System diagnostics with pads showed that the water flow rate (wfr) was 0 l/m, inlet pressure (ip) was -0.5psi, circulation pump command (cpc) was 100 percentage, mixing pump command (mpc) was 0, heater was 0, system hours were 13,600 and pump hours were 12,495.6.Placed device in manual control at 36c with no pads.System diagnostics showed that the water flow rate (wfr) was 1.8 l/m, inlet pressure (ip) was -6psi, circulation pump command (cpc) was 100 percentage, mixing pump command (mpc) was 0.Device alerted 47 control panel communication, so they rebooted device and the alert did not return.Walked through disabling manual control and have a couple devices.Suggested trying the pads on another device as this seems to be a device issue.If the new device works, send this device to biomed labelled low flow, patient line open and control panel communication error.Suggested to call back with any alerts.Biomed wanted to trouble shoot leaking valve on the fluid delivery line (fdl).
Additional Manufacturer Narrative
The reported issue was confirmed.The root cause of the reported issue is an air leak in the fluid delivery line.Nurse states had already disconnected and reconnected pads into different manifolds and confirmed connections.Targeted temperature (tt) was 36c, patient temperature (pt) was 36.7c, water temperature (wt) was 8.5c, water flow rate (wfr) was 0 l/m.System diagnostics with pads showed that the water flow rate (wfr) was 0 l/m, inlet pressure (ip) was -0.5psi, circulation pump command (cpc) was 100 percentage, mixing pump command (mpc) was 0, heater was 0, system hours were 13,600 and pump hours were 12,495.6.Placed device in manual control at 36c with no pads.System diagnostics showed that the water flow rate (wfr) was 1.8 l/m, inlet pressure (ip) was -6psi, circulation pump command (cpc) was 100 percentage, mixing pump command (mpc) was 0.Device alerted 47 control panel communication, so they rebooted device and the alert did not return.Walked through disabling manual control and have a couple devices.Suggested trying the pads on another device as this seems to be a device issue.If the new device works, send this device to biomed labelled low flow, patient line open and control panel communication error.Suggested to call back with any alerts.Biomed wanted to trouble shoot leaking valve on the fluid delivery line (fdl).The lot number for this investigation is unknown.The instructions-for-use were reviewed and 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 lot number is unknown.Based on the results of the investigation, no additional actions are needed.Corrections: d, 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 nurse recently began therapy and the arctic sun device now alerting patient line open and low flow.Nurse states had already disconnected and reconnected pads into different manifolds and confirmed connections.Targeted temperature (tt) was 36c, patient temperature (pt) was 36.7c, water temperature (wt) was 8.5c, water flow rate (wfr) was 0 l/m.System diagnostics with pads showed that the water flow rate (wfr) was 0 l/m, inlet pressure (ip) was -0.5psi, circulation pump command (cpc) was 100 percentage, mixing pump command (mpc) was 0, heater was 0, system hours were 13,600 and pump hours were 12,495.6.Placed device in manual control at 36c with no pads.System diagnostics showed that the water flow rate (wfr) was 1.8 l/m, inlet pressure (ip) was -6psi, circulation pump command (cpc) was 100 percentage, mixing pump command (mpc) was 0.Device alerted 47 control panel communication, so they rebooted device and the alert did not return.Walked through disabling manual control and have a couple devices.Suggested trying the pads on another device as this seems to be a device issue.If the new device works, send this device to biomed labelled low flow, patient line open and control panel communication error.Suggested to call back with any alerts.Biomed wanted to trouble shoot leaking valve on the fluid delivery line (fdl).
Event or Problem Description
It was reported that the nurse recently began therapy and the arctic sun device now alerting patient line open and low flow.Nurse states had already disconnected and reconnected pads into different manifolds and confirmed connections.Targeted temperature (tt) was 36c, patient temperature (pt) was 36.7c, water temperature (wt) was 8.5c, water flow rate (wfr) was 0 l/m.System diagnostics with pads showed that the water flow rate (wfr) was 0 l/m, inlet pressure (ip) was -0.5psi, circulation pump command (cpc) was 100 percentage, mixing pump command (mpc) was 0, heater was 0, system hours were 13,600 and pump hours were 12,495.6.Placed device in manual control at 36c with no pads.System diagnostics showed that the water flow rate (wfr) was 1.8 l/m, inlet pressure (ip) was -6psi, circulation pump command (cpc) was 100 percentage, mixing pump command (mpc) was 0.Device alerted 47 control panel communication, so they rebooted device and the alert did not return.Walked through disabling manual control and have a couple devices.Suggested trying the pads on another device as this seems to be a device issue.If the new device works, send this device to biomed labelled low flow, patient line open and control panel communication error.Suggested to call back with any alerts.Biomed wanted to trouble shoot leaking valve on the fluid delivery line (fdl).
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction: d, g.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.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, FLUID DELIVERY LINE
• Common Device Name: FLUID DELIVERY LINE
• 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: 23471904
• Report Number: 1018233-2025-09912
• Device Sequence Number: 18517204
• Product Code: DWJ
• UDI-Device Identifier: 00801741080265
• UDI-Public: (01)00801741080265
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 11/26/2025

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: 10/28/2025
• Supplement Date Received by Manufacturer: 11/25/2025; 11/26/2025
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 11/26/2025; 12/09/2025
• 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