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

Catalog Number	317-03
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the rewarming phase, arctic sun device flow rate was decreased below 0.2-0.3l/min.Customer did empty pads several times, reconnected all four pads and checked any leakage from pads.But the flow rate did not go up and the alarm number 01 (patient line open) went off.After all the customer's effort, they changed gel pads and the flow rate was maintained as 1.8-1.9l/min.
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 during the rewarming phase, arctic sun device flow rate was decreased below 0.2-0.3l/min.Customer did empty pads several times, reconnected all four pads and checked any leakage from pads.But the flow rate did not go up and the alarm number 01 (patient line open) went off.After all the customer's effort, they changed gel pads and the flow rate was maintained as 1.8-1.9l/min.
Additional Manufacturer Narrative
The reported event is confirmed cause unknown as they changed the pads and flow rate issue is solved.Sample was not available for evaluation.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The labeling is found to be adequate: 2.Select the proper number, size and style pad for the patient size and clinical indication.However, the rate of temperature change and potentially the final achievable temperature is affected by pad surface area, patient size, pad placement and water temperature range.Best system performance will be achieved by using the entire pad set (4).If the entire set of pads is not used, the minimum flow rate may not be achieved.3.For patient comfort, the pads may be prewarmed using water temperature control mode (manual) prior to application.4.Place the pads on healthy, clean skin only.Remove any creams or lotions from patient¿s skin before pad application.Remove the release liner from each pad and apply to the appropriate area.The pads may be overlapped or folded adhesive-to-adhesive to achieve proper placement.The pads may be removed and reapplied if necessary.The pad surface must be contacting the skin for optimal energy transfer efficiency.Place pads to allow for full respiratory excursion.5.Attach the pad¿s line connectors to the patient line manifolds.Begin circulating water through the pads using either patient temperature control mode (automatic) or water temperature control mode (manual).If the pads fail to prime or a significant continuous air leak is observed in the pad return line, check connections, then if needed replace the leaking pad.6.Once the pads are primed, assure the flow rate displayed on the control panel is greater than 1.7 liters per minute, which is the minimum flow rate for a full pad kit (4).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: ARCTICGEL 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: 20147642
• Report Number: 1018233-2024-05576
• Device Sequence Number: 4237225
• Product Code: DWJ
• UDI-Device Identifier: 10801741080040
• UDI-Public: (01)10801741080040(11)221006(17)240831(10)NGGV3906
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K142702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2025

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 Expiration Date: 08/31/2024
• Device Catalogue Number: 317-03
• Device Lot Number: NGGV3906
• 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: 08/29/2024
• Supplement Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2022
• 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