MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS; ARCTIC GEL 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	04/06/2026
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: 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 arctic sun device was alarming low flow, the water flow rate (wfr) was between 0.6 to 1 l/min.One of the connections has bubbles.Nurse stated they had each pad connected to a different leg of the fdl; they tried moving them to the same one, but this did not help.Had nurse pause therapy, empty the pad, and disconnect pad.Nurse confirmed there were no kinks in tubing.Had nurse reconnect pad with proper technique.Nurse resumed therapy.Nurse noticed a hissing/leak sound coming from the pad.Nurse will swap the pad out and will call back if they continue to have issues.Unable to get s/n before nurse hung up.Per follow up information received via phone on 07apr2026, transferred to the nicu.Spoke with charge nurse who noted two neonate pads had been used on this patient and pads were overlapped.They noted the patient had some exposed skin so two pads had to be used.They confirmed only one of the pads seemed faulty at the time, so they only exchanged one of the two pads.They believe the pad had been exposed of.There was no record of retention, and they have not seen it stored anywhere.
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 a dhr could not be performed since no lot number was provided.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 arctic sun device was alarming low flow, the water flow rate (wfr) was between 0.6 to 1 l/min.One of the connections has bubbles.Nurse stated they had each pad connected to a different leg of the fdl; they tried moving them to the same one, but this did not help.Had nurse pause therapy, empty the pad, and disconnect pad.Nurse confirmed there were no kinks in tubing.Had nurse reconnect pad with proper technique.Nurse resumed therapy.Nurse noticed a hissing/leak sound coming from the pad.Nurse will swap the pad out and will call back if they continue to have issues.Unable to get s/n before nurse hung up.Per follow up information received via phone on 07apr2026, transferred to the nicu.Spoke with charge nurse who noted two neonate pads had been used on this patient and pads were overlapped.They noted the patient had some exposed skin so two pads had to be used.They confirmed only one of the pads seemed faulty at the time, so they only exchanged one of the two pads.They believe the pad had been exposed of.There was no record of retention, and they have not seen it stored anywhere.

• 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, GA 30014 ; 7707846100
• MDR Report Key: 24839747
• Report Number: 1018233-2026-02392
• Device Sequence Number: 14940527
• Product Code: DWJ
• UDI-Device Identifier: 00801741132131
• UDI-Public: (01)00801741132131
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 04/06/2026
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 04/10/2026
• 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