MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS; NEONATAL 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	01/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the neonate rewarming.The arctic sun device was alerting 113 reduced water temperature control.Patient temperature (pt) was 36c, targeted temperature (tt) was 36.5c.Confirmed they added water earlier in the morning.Patient temperature (pt) was 36c, targeted temperature (tt) was 36.5c, water temperature (wt) was 23.1c, water flow rate (wfr) was 1.3 l/m.System diagnostics showed that the outlet monitor temperature (t1) was 23.7c, outlet control temperature (t2) was 23.5c, inlet temperature (t3) was 23.8c, chiller temperature (t4) was 7.3c, water flow rate (wfr) was 0.9 l/m, inlet pressure (ip) was -7psi, circulation pump command (cpc) was 38 percentage, mixing pump command (mpc) was 0, heater 69 percentage, water reservoir level (wrl) was 5, system hours were 2395.6 and pump hours were 2161.9.Walked through stop therapy, empty pads and device alerted empty pads not completed.Selected empty pads again.Had drain 16 ounces of water from right drain port.Restarted therapy and water flow rate (wfr) was 1 l/m.Advised would call back in 30 minutes to check on water temperature (wt).Called back and water flow rate (wfr) was dropped to 0.6 l/m and then 0.Advised to stop therapy and empty pads.Device alerted empty pads not completed.Selected empty pads again.Disconnected and reconnected using proper technique.Restarted therapy and water flow rate (wfr) was 0.8 l/m.Water flow rate (wfr) on neonatal pads has dropped to 0.5 l/m.Already tried addressing flow the last time they called.No neonatal pads available to swap out to.Had nurse check for small universal pads that could use with neonate instead but the only size available was xxs.Had connect 2 of the xxs pads and lay to the side.Water flow rate (wfr) was stabilized at 3.1 l/m.Explained needed to get the water flow rate (wfr) up to prevent the heater from shutting off and therefore allowing the patient temperature (pt) to rewarm.Encouraged to monitor water flow rate (wfr) and call back with any alerts/alarms.Per follow up information received via task on 03feb2026, spoke with charge nurse who stated the patient completed therapy and the pads were disposed of.The device remained in service without any evaluation.
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® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS
• Common Device Name: NEONATAL ARCTICGEL 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, GA 30014 ; 7707846100
• MDR Report Key: 24324365
• Report Number: 1018233-2026-00808
• Device Sequence Number: 9674237
• Product Code: DWJ
• UDI-Device Identifier: 00801741132131
• UDI-Public: (01)00801741132131
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/19/2026

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: 01/30/2026
• Supplement Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 06/29/2026
• 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