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

Catalog Number	317-00
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2024
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 nurse stated that they were trying to start therapy on a patient in an arctic sun device.They keep receiving a low flow alarm 01 and 02.They have tried switching the machine out, but they were getting the same alarm.Nurse provided s/n dyzfy013 for current machine.Confirmed they have a set of 4 pads and a universal pad connected.Had nurse stop, empty pads, and disconnect pads.Had nurse confirm no kinks or bends in tubing, reconnected pads with proper technique.Resumed therapy, device primed to water flow rate (wfr) was 0 l/min.Had nurse stop, empty the pads and disconnect.Walked nurse through placing device in manual control.Without pads, water flow rate (wfr) was 2.1 l/min, inlet pressure (ip) was -8.1psi, circulation pump command (cpc) was 79 percentage, system hours 5,026, and pump hours 4,307.Had nurse connect one pad at a time, right chest, wfr 1.8 l/min, inlet pressure (ip) was -2.1psi, circulation pump command (cpc) was 100 percentage.Added right leg, water flow rate (wfr) was 1.4 l/min, inlet pressure (ip) was -2psi, circulation pump command (cpc) was 100 percentage.Added left leg, water flow rate (wfr) was 1.4 l/min, inlet pressure (ip) was -1.4psi, circulation pump command (cpc) was 100 percentage.Added left chest, water flow rate (wfr) was 1.2 l/min, inlet pressure (ip) was -1.2psi, and circulation pump command (cpc) was 100 percentage.Informed nurse it may be the circulation pump.Suggested to try connecting the pads to the first.
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.The labeling is found to be adequate.A dhr could not be performed since no lot number was provided.Correction: d,e.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 nurse stated that they were trying to start therapy on a patient in an arctic sun device.They keep receiving a low flow alarm 01 and 02.They have tried switching the machine out, but they were getting the same alarm.Nurse provided s/n (b)(6) for current machine.Confirmed they have a set of 4 pads and a universal pad connected.Had nurse stop, empty pads, and disconnect pads.Had nurse confirm no kinks or bends in tubing, reconnected pads with proper technique.Resumed therapy, device primed to water flow rate (wfr) was 0 l/min.Had nurse stop, empty the pads and disconnect.Walked nurse through placing device in manual control.Without pads, water flow rate (wfr) was 2.1 l/min, inlet pressure (ip) was -8.1psi, circulation pump command (cpc) was 79 percentage, system hours 5,026, and pump hours 4,307.Had nurse connect one pad at a time, right chest, wfr 1.8 l/min, inlet pressure (ip) was -2.1psi, circulation pump command (cpc) was 100 percentage.Added right leg, water flow rate (wfr) was 1.4 l/min, inlet pressure (ip) was -2psi, circulation pump command (cpc) was 100 percentage.Added left leg, water flow rate (wfr) was 1.4 l/min, inlet pressure (ip) was -1.4psi, circulation pump command (cpc) was 100 percentage.Added left chest, water flow rate (wfr) was 1.2 l/min, inlet pressure (ip) was -1.2psi, and circulation pump command (cpc) was 100 percentage.Informed nurse it may be the circulation pump.Suggested to try connecting the pads to the first.

• 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: 20987010
• Report Number: 1018233-2024-08153
• Device Sequence Number: 8443365
• Product Code: DWJ
• UDI-Device Identifier: 00801741080005
• UDI-Public: (01)00801741080005
• 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,Followup
• Report Date (Section B): 04/16/2025

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: 317-00
• 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: 12/14/2024
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 12/20/2024
• Supplement Report FDA Received Date: 04/21/2025
• 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