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

Catalog Number	318-02
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
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: sections 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 nicu nurse getting alert 113 (reduced water temp control) in an arctic sun device.Patient temperature (pt) was 33.2c, targeted temperature (tt) was 33.5c, water temperature (wt) was 29.6c, flow rate (fr) was 0.2lpm.Explained the correlation between flow rate and heater capacity.The tubing was looped so we adjusted the tubing and disconnected the pads then reconnected using proper technique.Flow rate (fr) settled at 0.9lpm.Guided to diagnostics: system hours 1939, pump hours 1824, inlet pressure (ip) was -7psi, circulation pump command (cpc) was 100 percent, flow rate (fr) was 0.9lpm.They will call back if they have any other issues.Per follow up information received via phone on 17feb2026, spoke with the charge nurse who confirmed pad was neonate size and was used through the remainder of treatment.They did not recall any therapy materials being retained for a return.They would double check.Took information.
Event or Problem Description
It was reported that nicu nurse getting alert 113 (reduced water temp control) in an arctic sun device.Patient temperature (pt) was 33.2c, targeted temperature (tt) was 33.5c, water temperature (wt) was 29.6c, flow rate (fr) was 0.2lpm.Explained the correlation between flow rate and heater capacity.The tubing was looped so we adjusted the tubing and disconnected the pads then reconnected using proper technique.Flow rate (fr) settled at 0.9lpm.Guided to diagnostics: system hours 1939, pump hours 1824, inlet pressure (ip) was -7psi, circulation pump command (cpc) was 100%, flow rate (fr) was 0.9lpm.They will call back if they have any other issues.Per follow up information received via phone on 17feb2026, spoke with charge nurse who confirmed pad was neonate size and was used through the remainder of treatment.They did not recall any therapy materials being retained for a return.They would double check.Took information.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.The dhr review could not be performed without a lot number.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® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS
• Common Device Name: ARCTICGEL PADS
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville CO 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: 24442673
• Report Number: 1018233-2026-01200
• Device Sequence Number: 10212454
• Product Code: DWJ
• UDI-Device Identifier: 00801741132131
• UDI-Public: (01)00801741132131
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• 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: 318-02
• 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: 02/16/2026
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 04/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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