MAUDE Adverse Event Report: MEDIVANCE -1725056 Arctic Sun® Temperature Management System, ArcticGel¿ Pads; Neonatal 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	04/11/2026
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 water flow rate dropped below 1.1lpm so they stopped therapy and refilled the reservoir.Now they are getting alarm 02 (low flow) and the flow rate was 0.6lpm in an arctic sun device s/n (b)(6).Flow rate (fr) was 0.5lpm, inlet pressure (ip) was negative 6.9psi, circulation pump command (cpc) was 26%, pump hours 669.3, system hours 726.9.Device shows low air leak now.Patient down to 33.2c.Nurse wants to know if they need to add more water.Explained the device will alarm if the reservoir was empty.Explained causes of low flow.Asked nurse to feel for any kinks or compression of the pad tubing.Nurse was able to identify a kink.Flow now 0.9lpm.Advised watching the flow rate.If the flow drops to 0.5 to 0.6lpm and they cannot get it to increase, replace the pad.Per follow up information received via phone on 13apr2026, transferred to the 5th floor nicu.Spoke with nurse who confirmed no further issues after troubleshooting.The flow did remain under 1.1 lpm, but the air leak message disappeared after adjusting the kink in the pad tubing.Pad was disposed of after therapy completed and device remained in service.Neither the device or pad were individually inspected for faults.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction - d, g, 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 water flow rate dropped below 1.1lpm so they stopped therapy and refilled the reservoir.Now they are getting alarm 02 (low flow) and the flow rate was 0.6lpm in an arctic sun device s/n: (b)(6).Flow rate (fr) was 0.5lpm, inlet pressure (ip) was negative 6.9psi, circulation pump command (cpc) was 26%, pump hours 669.3, system hours 726.9.Device shows low air leak now.Patient down to 33.2c.Nurse wants to know if they need to add more water.Explained the device will alarm if the reservoir was empty.Explained causes of low flow.Asked nurse to feel for any kinks or compression of the pad tubing.Nurse was able to identify a kink.Flow now 0.9lpm.Advised watching the flow rate.If the flow drops to 0.5 to 0.6lpm and they cannot get it to increase, replace the pad.Per follow up information received via phone on 13apr2026, transferred to the 5th floor nicu.Spoke with nurse who confirmed no further issues after troubleshooting.The flow did remain under 1.1 lpm, but the air leak message disappeared after adjusting the kink in the pad tubing.Pad was disposed of after therapy completed and device remained in service.Neither the device nor pad were individually inspected for faults.Per additional information received via phone on 15apr2026, biomed also wanting review a case on s/n: (b)(6), this device was having issues with the baby temp dropping below the cooling target and not warming up.Informed biomed there was a case from the nurses on the 11th regarding low flow.They were able to troubleshoot and get the flow rate up to 0.9 l/min.Explained causes of low flow.Discussed low flow and correlation to heater function.If the flow rate was dropping, this could have led to issues with the water heating and heating the patient.Offered to transfer to tech support to review case data download if he would like, biomed stated they will talk further with the nicu and call back if needed.Spoke with biomed who reviewed the patient data for sn: (b)(6), they saw the flow rate had dropped to 0.3 lpm for several minutes at the initiation of therapy.They saw several fluctuations ranging from 0.3-0.7 lpm for the next hour, then the troubleshooting that rose the flow to 0.9 lpm.The temperature drops correlate with the flow rate going under 0.5 lpm.They suspected this was an issue with the pad only.The device passed verification check and will go back to the floor today.

• Brand Name: Arctic Sun® Temperature Management System, ArcticGel¿ Pads
• Common Device Name: Neonatal Arctic Gel Pads
• Manufacturer (Section D): MEDIVANCE -1725056; 321 south taylor ave; suite 200; louisville CO 80027
• Manufacturer (Section G): MEDIVANCE -1725056; 321 south taylor ave; suite 200; louisville CO 80027
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; +1(770)784-6100
• MDR Report Key: 24889517
• Report Number: 1018233-2026-02502
• Device Sequence Number: 9851676
• Product Code: DWJ
• UDI-Device Identifier: 00801741132131
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 07/23/2026

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2026
• Supplement Date Received by Manufacturer: 04/16/2026; 07/23/2026
• Initial Report FDA Received Date: 04/15/2026
• Supplement Report FDA Received Date: 04/22/2026; 07/27/2026
• 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