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

Catalog Number	60000000L
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device still has same issue with previous wo: (b)(4), even though it was repaired by dymax (received in kr on 18 nov after repair).This needs repeat repair (within 90 days) and will be sent to dymax again.(feb,19, 2025), this will be repaired in south korea, not dymax.We will start to repair once the arcticsun stat spare part has arrived.Per sample evaluation results received via task on 03apr2025, it was reported that the alert 113 found in event log history, faulty chiller.
Additional Manufacturer Narrative
The reported issue was confirmed.The root cause identified is a failed chiller.The device was evaluated upon receipt.Tested the device in manual mode, set the water temperature to 4 degrees and operated the device, but even after 2 hours, the water temperature did not cool down below 15 degrees.This test was repeated several times, but the same symptoms occurred, and the chiller pump assy.Operated normally.Replaced chiller.After completion of service, the device passed functional verification and electrical safety testing.Per baw2800349 (arctic sun¿ stat temperature management system service manual) rev.2 and sr-03-ttmt-0003 rev.4, the device meets all specifications.Ctu calibration performed.A dhr review is not required as the device has undergone previous servicing and therefore the reported issue is not manufacturing related.The complaint or reported issue was confirmed through other elements of the investigation to not be labeling or packaging related.Correction: 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.
Event or Problem Description
It was reported that the device still has same issue with previous wo ((b)(4)), even though it was repaired by dymax (received in kr on 18 nov after repair).This needs repeat repair (within 90 days) and will be sent to dymax again.(feb,19, 2025) this will be repaired in south korea, not dymax.We will start to repair once the arcticsun stat spare part is arrived.Per sample evaluation results received via task on 03apr2025, it was reported that the alert 113 found in event log history, faulty chiller.
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 device still has same issue with previous wo((b)(4)), even though it was repaired by dymax (received in kr on 18 nov after repair).This needs repeat repair (within 90 days) and will be sent to dymax again.(feb,19, 2025) this will be repaired in south korea, not dymax.We'll start to repair once the arcticsun stat spare part is arrived.Per sample evaluation results received via task on 03apr2025, it was reported that the alert 113 found in event log history, faulty chiller.
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.

• 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: 21827333
• Report Number: 1018233-2025-02577
• Device Sequence Number: 9373810
• Product Code: DWJ
• UDI-Device Identifier: 00801741161520
• UDI-Public: (01)00801741161520(11)230822
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 05/08/2025

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
• Date Returned to Manufacturer: 01/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2025
• Supplement Date Received by Manufacturer: 04/11/2025; 05/08/2025
• Initial Report FDA Received Date: 04/11/2025
• Supplement Report FDA Received Date: 04/14/2025; 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2023
• 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