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

Catalog Number	60000000L
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 they were getting low flow in an arctic sun device earlier.They were able to get it resolved.Therapy ran well for a few hours, but now they were getting low flow alerts again (alarm 02).Flow rate (fr) was 0lpm, inlet pressure (ip) was -9psi, circulation pump command (cpc) was 0 percentage.Suggested changing to another device.Nurse located s/n dygxal029 and called back.Patient connected to new device, therapy started.Flow rate (fr) was 1.1lpm, inlet pressure (ip) was -7psi, circulation pump command (cpc) was 34 percentage pump hours were 2621, system hours were 2730.Duration adjusted to match first device 63:24.Suggested sending first device to biomed.Therapy continued on second device.
Additional Manufacturer Narrative
Upon further review, bd has determined that this mdr was reported in error as it was found to be a duplicate of an event previously reported 1018233-2025-04089.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 they were getting low flow in an arctic sun device earlier.They were able to get it resolved.Therapy ran well for a few hours, but now they were getting low flow alerts again (alarm 02).Flow rate (fr) was 0lpm, inlet pressure (ip) was -9psi, circulation pump command (cpc) was 0 percentage.Suggested changing to another device.Nurse located s/n (b)(6) and called back.Patient connected to new device, therapy started.Flow rate (fr) was 1.1lpm, inlet pressure (ip) was -7psi, circulation pump command (cpc) was 34 percentage pump hours were 2621, system hours were 2730.Duration adjusted to match first device ~63:24.Suggested sending first device to biomed.Therapy continued on second device.

• 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: 22151902
• Report Number: 1018233-2025-04202
• Device Sequence Number: 7849613
• Product Code: DWJ
• UDI-Device Identifier: 00801741161520
• UDI-Public: (01)00801741161520
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 09/12/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 09/11/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 09/12/2025
• 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