MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS; ARCTIC GEL PADS

Catalog Number	317-02
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported issue was confirmed.The root cause of the reported issue is a disconnection of the tubing from the port barbs of the connector.Visual evaluation of the returned sample noted a xxs thigh pad from a kit present with no original packaging.One photo sample was returned for evaluation.Visual inspection noted the following: * the photo shows disconnection at the end of the tubing to the connector and what looks to be a tear in the foam on the tubing jacket.* no obvious visible defects such as cuts or tears in the foam.*no visible chips or deformities at the ends of connector.Disconnection at the end of the connector on one side.* tubing for all the pad noted no kinks present.* hydrogel was intact with pad and not separated.* no crushed dimples or signs of overlamination in the pad.* water still located in the pad.The reported issue could not be verified without further testing.Flow test is not required because the disconnected tubing from the connector would result in a continuous air leak.The sample does not meet specifications which state ""the plastic tube must be completely assembled, covering the total of clamping rings on the plastic connector and manifold connector according to the visual aid (b)(6)." 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.A dhr review is not required as the lot number is unknown.All available udi information is being provided.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 picu nurse starting new therapy and was getting alert 02 (low flow).The arctic sun device primed and stopped.Guided to diagnostics showed that the system hours were 4777, pump hours were 3058, inlet pressure (ip) was -0.2psi, circulation pump command (cpc) was 100 percentage, flow rate (fr) was 0lpm.As we were disconnecting the pads, they noticed damage to one of the pad connectors.They would replace these pads.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS
• Common Device Name: ARCTIC GEL PADS
• 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 30014 ; 7707846100
• MDR Report Key: 24973955
• Report Number: 1018233-2026-02667
• Device Sequence Number: 4954814
• Product Code: DWJ
• UDI-Device Identifier: 00801741080029
• UDI-Public: (01)00801741080029
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K142702
• 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
• Report Date (Section B): 04/22/2026

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: 317-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown