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	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the nurse stated that they were trying to start therapy on a patient.The arctic sun device was alarming 01 patient line open.They tried disconnecting and reconnecting the pads and then rebooting the device.Current water flow rate (wfr) was 0.Confirmed they were using a neonatal pad and a universal pad.Had nurse stop therapy, empty the pads, and disconnect the pads.Walked nurse through placing device in manual control.Without pads water flow rate (wfr) was 1.9 l/min, inlet pressure (ip) was -7psi, circulation pump command (cpc) was 51 percentage, system hours were 8,376, and pump hours were 7,424.Had nurse connect neonatal pad, water flow rate (wfr) was 1.3 l/min, inlet pressure (ip) was -0.7psi, and circulation pump command (cpc) was 100 percentage.Nurse confirmed pad connection clicked in; tubing was straight.Had nurse disconnect pad and try connecting to another port, water flow rate (wfr) was 1.2 l/min, inlet pressure (ip) was -0.6psi, and circulation pump command (cpc) was 100 percentage.Nurse might be hearing a hissing sound coming from the pad.Had nurse disconnect neonatal pad and connect the universal pad, water flow rate (wfr) was 0.8 l/min, inlet pressure (ip) was -7.8psi, and circulation pump command (cpc) was 54 percentage.Nurse replaced neonatal pad and connected new pad, water flow rate (wfr) was 2.8 l/min, inlet pressure (ip) was -9.5psi, and circulation pump command (cpc) was 52 percentage.Disabled manual control and resumed therapy, after a few minutes water flow rate (wfr) was 2 l/min.Informed nurse to hold onto the first neonatal pad for our field assurance team, lot# ngjvy601.Encouraged nurse to call with any issues.
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.The arctic sun device was alarming 01 patient line open.They tried disconnecting and reconnecting the pads and then rebooting the device.Current water flow rate (wfr) was 0.Confirmed they were using a neonatal pad and a universal pad.Had nurse stop therapy, empty the pads, and disconnect the pads.Walked nurse through placing device in manual control.Without pads water flow rate (wfr) was 1.9 l/min, inlet pressure (ip) was -7psi, circulation pump command (cpc) was 51 percentage, system hours were 8,376, and pump hours were 7,424.Had nurse connect neonatal pad, water flow rate (wfr) was 1.3 l/min, inlet pressure (ip) was -0.7psi, and circulation pump command (cpc) was 100 percentage.Nurse confirmed pad connection clicked in; tubing was straight.Had nurse disconnect pad and try connecting to another port, water flow rate (wfr) was 1.2 l/min, inlet pressure (ip) was -0.6psi, and circulation pump command (cpc) was 100 percentage.Nurse might be hearing a hissing sound coming from the pad.Had nurse disconnect neonatal pad and connect the universal pad, water flow rate (wfr) was 0.8 l/min, inlet pressure (ip) was -7.8psi, and circulation pump command (cpc) was 54 percentage.Nurse replaced neonatal pad and connected new pad, water flow rate (wfr) was 2.8 l/min, inlet pressure (ip) was -9.5psi, and circulation pump command (cpc) was 52 percentage.Disabled manual control and resumed therapy, after a few minutes water flow rate (wfr) was 2 l/min.Informed nurse to hold onto the first neonatal pad for our field assurance team, lot#: ngjvy601.Encouraged nurse to call with any issues.Per follow up information received via task on 12feb2025, per review of event, bd representative successfully troubleshot the malfunction during the call.The event concluded with the device working and the patient on the trajectory for successful therapy completion.
Additional Manufacturer Narrative
The device was not returned.The reported issue was inconclusive.The root cause of the reported issue could not be identified.The nurse stated that they were trying to start therapy on a patient.The arctic sun device was alarming 01 patient line open.They tried disconnecting and reconnecting the pads and then rebooting the device.Current water flow rate (wfr) was 0.Confirmed they were using a neonatal pad and a universal pad.Had nurse stop therapy, empty the pads, and disconnect the pads.Walked nurse through placing device in manual control.Without pads water flow rate (wfr) was 1.9 l/min, inlet pressure (ip) was -7psi, circulation pump command (cpc) was 51 percentage, system hours were 8,376, and pump hours were 7,424.Had nurse connect neonatal pad, water flow rate (wfr) was 1.3 l/min, inlet pressure (ip) was -0.7psi, and circulation pump command (cpc) was 100 percentage.Nurse confirmed pad connection clicked in, tubing was straight.Had nurse disconnect pad and try connecting to another port, water flow rate (wfr) was 1.2 l/min, inlet pressure (ip) was -0.6psi, and circulation pump command (cpc) was 100 percentage.Nurse might be hearing a hissing sound coming from the pad.Had nurse disconnect neonatal pad and connect the universal pad, water flow rate (wfr) was 0.8 l/min, inlet pressure (ip) was -7.8psi, and circulation pump command (cpc) was 54 percentage.Nurse replaced neonatal pad and connected new pad, water flow rate (wfr) was 2.8 l/min, inlet pressure (ip) was -9.5psi, and circulation pump command (cpc) was 52 percentage.Disabled manual control and resumed therapy, after a few minutes water flow rate (wfr) was 2 l/min.Informed nurse to hold onto the first neonatal pad for our field assurance team, lot: ngjvy601.Encouraged nurse to call with any issues.Per follow up information received via task on 12feb2025, per review of event, bd representative successfully troubleshot the malfunction during the call.The event concluded with the device working and the patient on the trajectory for successful therapy completion.The instructions-for-use were reviewed and found to be adequate.The ifu currently instructs the user on the proper method to use this device to avoid undue injury to the patient and damage to the product.A dhr review is not required as the serial/lot number is unknown.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
• 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: 21364959
• Report Number: 1018233-2025-00848
• Device Sequence Number: 8452187
• Product Code: DWJ
• UDI-Device Identifier: 00801741080005
• UDI-Public: (01)00801741080005
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 04/01/2025

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: 02/07/2025
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 04/03/2025
• 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