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

Catalog Number	317-07
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the nurse has been trying to start therapy for some time.They tried two arctic sun devices and two brand new sets of pads already.Had disconnect and reconnect using proper technique.Restarted therapy and flow rate (fr) went to 0lpm.Guided to diagnostics showed that the system hours were 2256, pump hours were 2070, inlet pressure (ip) was -0.6psi, circulation pump command (cpc) was 100 percentage, flow rate (fr) was 0lpm.Tried second device ((b)(6)).System hours were 162, pump hours were 95, inlet pressure (ip) was -4.2psi, circulation pump command (cpc) was 100 percentage, flow rate (fr) was 1.2lpm (medium size pads).Stopped therapy, drained pads and placed device in manual control.No pads attached, inlet pressure (ip) was -7psi, circulation pump command (cpc) was 65 percentage, flow rate (fr) was 1.9lpm.The next pad got another page.Since this was a time-consuming process and did not wish to leave the other customers waiting, they instructed on how to watch for stable inlet pressure (ip) was at -7psi and added the pads one at a time.After speaking to the other customer, they called back, then added the right chest and thigh and both stabilized at -7psi, however when added the left chest pad the inlet pressure (ip) went to -2.3psi.Suggested removing this pad and replacing it with a universal pad.They had plugged the device into a bed while was on the other line (unclear why), so reconnected to a wall outlet, turned device back on, ensured manual control was disabled, connected a universal pad in place of left chest pad and restarted therapy.Flow rate (fr) was 3.3lpm at this time.Advised could return this pad for investigation (already disposed of the first set).Please ask during the day to coordinate the pad return.Per follow up information received via task on (b)(6) 2026, spoke with charge nurse who had brief notes on this event and those notes did not include information about a faulty device.Only the pad was mentioned, which has been placed in the storage closet.They had one from the set and the rest seem to be disposed of and requested the box sent to the micu to avoid delays in receipt.
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: ARCTIC GEL PADS COOLING KIT
• 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: 24292017
• Report Number: 1018233-2026-00723
• Device Sequence Number: 10382222
• Product Code: DWJ
• UDI-Device Identifier: 00801741080081
• UDI-Public: (01)00801741080081
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/29/2026

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: 317-07
• 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: 01/28/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 06/09/2026
• 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