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

Catalog Number	318-02-02
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2026
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 arctic sun device is alarming low flow (alarm 02) and therapy has shut off.They changed the orientation of the tubing.The nurse stated the flow dropped to 0 lpm, so going to change the pad out.Nurse stated that the flow was 0 lpm, inlet pressure was -7psi, circulation pump command was 34 percentage.The flow was 1.8 lpm, -7.3psi, 73 percentage.Pump hours were 1263.System hours were 4480.Flow dropped to 1.1 lpm and inlet pressure was -7.8 psi.There was alarm 113 (reduced water temperature control) in the event log.Nurse confirmed that pads were connected properly and moved the tubing around.The flow was 0.8lpm, -7.1psi.If the flow dropped to 0.5lpm, the heater would not be able to work appropriately, leading to alarm 113.Walked the nurse through replacing the pad.The flow with new pad was 0.9 lpm, -7.3psi, 33 percentage.Nurse removed the fluid delivery line and inlet pressure dropped to 0 lpm.Replaced the fluid delivery line 0.9 lpm, -7psi, 36 percentage.Asked the nurse to keep an eye of flow rate and to call back if it drops again.Per follow up information received on 22jun2026, nurse stated that the flow had dropped back down to zero again.They had tried reconnecting the pad and the fluid delivery line again, but the flow remained low and unstable.They noted a soft "hissing" sound coming from the area where the fluid delivery line attached.They did not know how to exchange only the tube, so they swapped devices and sent this device to the biomed.No further issues after device exchanged.

• 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): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 25630814
• Report Number: 1018233-2026-04149
• Device Sequence Number: 15797528
• Product Code: DWJ
• UDI-Device Identifier: 00801741132131
• UDI-Public: (01)00801741132131(17)270831(10)NGKW1603
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 06/23/2026

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: 318-02-02
• Device Lot Number: NGKW1603
• 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: 06/20/2026
• Initial Report FDA Received Date: 06/25/2026
• 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