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

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	04/12/2026
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 in the last 10 to 15 minutes they got a low flow alert (02) in an arctic sun device.They checked the connections but could not get the flow rate to increase.Flow was 0.7lpm.Flow was 0.7lpm, inlet pressure (ip) was negative 7.0psi, circulation pump command (cpc) was 35 percentage, pump hours were 2354.5 and system hours were 2425.5.Asked nurse to feel for any kinks or flat sections in the pad tubing.They were able to find one section that was flat.When they squeeze it open, it goes flat again.Flow was 0.8lpm.Baby at target.Suggested continuing to attempt to keep that section of the tubing open and monitoring flow rate.If the flow rate drops more, replace pad as the heater would not be able to work at full capacity.Per follow up information received via phone on (b)(6) 2026, spoke with charge nurse who stated they decided to exchange the infant pad for a new one because the tube continued to deflate.The flow rate continued to drop due to the flattening of the tube, and they were concerned it would not work in rewarm mode.The new pad worked without issue and therapy completed.Requested a sample collection box.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS
• Common Device Name: ARCTIC GEL NEONATAL PAD
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; suite 200; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 24889518
• Report Number: 1018233-2026-02504
• Device Sequence Number: 9851677
• Product Code: DWJ
• UDI-Device Identifier: 00801741132131
• UDI-Public: (01)00801741132131
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 05/21/2026

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: 04/12/2026
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 04/15/2026
• Supplement Report FDA Received Date: 05/29/2026
• 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