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

Catalog Number	60000000L
Medical Device Problem Codes	Restricted Flow rate (1248); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2025
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.The reported product number is unknown.The udi number for this product is not available.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 stated they were trying to troubleshoot low flow on arctic sun device sn#dygyal006.They tried to empty the pads and was getting an empty pads not complete alert.Had them disconnected pads and attempt to fill device.Device would not fill, reconnected pads and tried to start therapy but got a reservoir empty alarm (05).Guided to therapy screen and attempted to drain pads but again got a failure to complete.Guided to diagnostics, system hours 100, pump hours 65, inlet pressure (ip) was -11psi, circulation pump command (cpc) was 0 percentage, flow rate (fr) was 0lpm.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction: d, e, f, g, 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 stated they were trying to troubleshoot low flow on arctic sun device sn#(b)(6).They tried to empty the pads and was getting an empty pads not complete alert.Had them disconnected pads and attempt to fill device.Device would not fill.Reconnected pads and tried to start therapy but got a reservoir empty alarm (05).Guided to therapy screen and attempted to drain pads but again got a failure to complete.Guided to diagnostics, system hours 100, pump hours 65, inlet pressure (ip) was -11psi, circulation pump command (cpc) was 0 percentage, flow rate (fr) was 0lpm.
Event or Problem Description
It was reported that the nurse stated they were trying to troubleshoot low flow on arctic sun device sn# (b)(6).They tried to empty the pads and was getting an empty pads not complete alert.Had them disconnected pads and attempt to fill device.Device would not fill.Reconnected pads and tried to start therapy but got a reservoir empty alarm (05).Guided to therapy screen and attempted to drain pads but again got a failure to complete.Guided to diagnostics, system hours 100, pump hours 65, inlet pressure (ip) was -11psi, circulation pump command (cpc) was 0 percentage, flow rate (fr) was 0lpm.Per follow up information received via task on 29apr2025, biomed stated that the user sent the device down for pressure issues.Checked the even log and saw 07 and 02 alerts over the weekend, they ran a functional check in bypass, -7.0 psi, flow rate (fr) was 1.8 lpm, circulation pump command (cpc) was 45 percentage, device heated and cooled fine, connected a shunt and got flow rate (fr) 4.1 lpm, inlet pressure (ip) was -7.0, circulation pump command (cpc) was 98 percentage.
Additional Manufacturer Narrative
Restricted flow rate: the reported issue was unconfirmed.The root cause of the reported issue could not be determined as the reported issue could not be reproduced.The device was evaluated upon receipt.During the functional testing the unit filled up normally.During the functional testing the unit did not experience any issues (heats above 30°c and cools below 6°c and is stable at 28°c with a flow of 1.8 l/m with -7.0 psi in bypass mode).During a ctu calibration of the unit an error 90 was shown, so a ctu calibration was restarted and an error 2 was shown during calibration.Replaced pressure transducer.The unit passed all tests, is functioning properly and is ready for use.The labeling/packaging review is not required as the reported event is unconfirmed.A dhr review is not required as the reported event is unconfirmed.Gas leak: the reported issue was confirmed.The root cause identified is a failed pressure transducer.The device was evaluated upon receipt.During the functional testing the unit did not experience any issues (heats above 30°c and cools below 6°c and is stable at 28°c with a flow of 1.8 l/m with -7.0 psi in bypass mode).During a ctu calibration of the unit an error 90 was shown, so a ctu calibration was restarted and an error 2 was shown during calibration.Replaced pressure transducer.The unit passed all tests, is functioning properly and is ready for use.The complaint or reported issue was confirmed through other elements of the investigation to not be labeling or packaging related.A dhr review is not required as the reported event is not an out of box failure and therefore the reported event is not manufacturing related.Correction: b, d, 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.

• Brand Name: ARCTIC SUN STAT
• 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 80027
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 21385491
• Report Number: 1018233-2025-00937
• Device Sequence Number: 8291766
• Product Code: DWJ
• UDI-Device Identifier: 00801741161520
• UDI-Public: (01)00801741161520(11)221103
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K200225
• 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): 08/01/2025

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: 60000000L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2025
• Supplement Date Received by Manufacturer: 03/20/2025; 07/31/2025
• Initial Report FDA Received Date: 02/14/2025
• Supplement Report FDA Received Date: 03/24/2025; 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2022
• 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