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

Catalog Number	50000000L
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2025
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 had arctic sun device alerting low flow, but patient was at target.Had stop therapy, empty pads and disconnect.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.System diagnostics: showed that the water flow rate (wfr) was 0 l/m, inlet pressure (ip) was -3.3psi, circulation pump command (cpc) was 100 percentage, mixing pump command (mpc) was 0, heater was 0, system hours were 10,832 and pump hours were 9771.Had rn remove the pads and place device in manual control.Circulation pump command (cpc) was 45 percentage, mixing pump command (mpc) was 0, flow rate (fr) was 0 l/m, inlet pressure (ip) was -7.Explained to inquirer this sounds like a flow meter issue.Had stop therapy and disable manual control.Walked through swapping device and sending device down for biomed evaluation labelled low flow.
Additional Manufacturer Narrative
The reported issue was inconclusive.The root cause for the reported event could not be determined.Had stop therapy, empty pads and disconnect.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.System diagnostics: showed that the water flow rate (wfr) was 0 l/m, inlet pressure (ip) was -3.3psi, circulation pump command (cpc) was 100 percentage, mixing pump command (mpc) was 0, heater was 0, system hours were 10,832 and pump hours were 9771.Had rn remove the pads and place device in manual control.Circulation pump command (cpc) was 45 percentage, mixing pump command (mpc) was 0, flow rate (fr) was 0 l/m, inlet pressure (ip) was -7.Explained to inquirer this sounds like a flow meter issue.Had stop therapy and disable manual control.Walked through swapping device and sending device down for biomed evaluation labelled low flow.The complaint or reported issue was confirmed through other elements of the investigation to not be manufacturing related.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.Correction: d, 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.
Event or Problem Description
It was reported that the nurse had arctic sun device alerting low flow, but patient was at target.Had stop therapy, empty pads and disconnect.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.System diagnostics: showed that the water flow rate (wfr) was 0 l/m, inlet pressure (ip) was -3.3psi, circulation pump command (cpc) was 100 percentage, mixing pump command (mpc) was 0, heater was 0, system hours were 10,832 and pump hours were 9771.Had rn remove the pads and place device in manual control.Circulation pump command (cpc) was 45 percentage, mixing pump command (mpc) was 0, flow rate (fr) was 0 l/m, inlet pressure (ip) was -7.Explained to inquirer this sounds like a flow meter issue.Had stop therapy and disable manual control.Walked through swapping device and sending device down for biomed evaluation labelled low flow.

• 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: 21934188
• Report Number: 1018233-2025-03113
• Device Sequence Number: 20184561
• Product Code: DWJ
• UDI-Device Identifier: 00801741080159
• UDI-Public: (01)00801741080159(11)160301
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 07/17/2025

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: 50000000L
• 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: 04/25/2025
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2016
• 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