MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN DEVICE

Model Number 60000000

Device Problems Insufficient Heating (1287); Overfill (2404)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/13/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the nurse stated the patient was not rewarming on the arctic sun device.The nurse wanted to know if the device was working appropriately.The patient temperature was 33.6c, target temperature was 37c, water temperature was 30.4c and flow rate was 3.0lpm.Rewarm from 35.5 c and rewarm rate was 0.33c/hour.When mss walked the nurse through alerts and alarms, alert 113 (reduced water temperature control) was noted.Operating hours were 73, system hours were 102 and heater command was 100 percent.Mss explained how to drain 500 cc off the device and placed the device in manual control with water temperature at 40c.Water temperature immediately went to 38c, and nurse disabled manual mode.Now the patient temperature was 33.8c and water temperature was 37c.

Manufacturer Narrative

The reported issue was confirmed.The root cause of the reported issue was isolated to user related.It is known that the device did not meet specifications and whether the device was influenced by the reported failure.The device was in use on a patient.The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "1) drain the reservoir.¿ turn control module power off.¿ attach the drain line to the two drain ports on the back of the control module.Place the end of the drain line into a container.The water will passively drain into the container.2) refill the reservoir.¿ connect the fill tube.¿ from the hypothermia therapy screen or the normothermia therapy screen, press the fill reservoir button.¿ the fill reservoir screen will appear.Follow the directions on the screen.¿ add one vial of arctic sun¿ temperature management system cleaning solution to the second liter of sterile water.¿ the filling process will automatically stop when the reservoir is full.Continue to replace the bottles of sterile water until the filling process stops.¿ when the fill reservoir process is complete, the screen will close.Note: the reservoir level sensor requires a conductive fluid to operate properly.Filling the reservoir without using the arctic sun cleaning solution may result in overfilling the reservoir." the device was not returned.

Event Description

It was reported that the nurse stated the patient was not rewarming on the arctic sun device.The nurse wanted to know if the device was working appropriately.The patient temperature was 33.6c, target temperature was 37c, water temperature was 30.4c and flow rate was 3.0lpm.Rewarm from 35.5 c and rewarm rate was 0.33c/hour.When mss walked the nurse through alerts and alarms, alert 113 (reduced water temperature control) was noted.Operating hours were 73, system hours were 102 and heater command was 100 percent.Mss explained how to drain 500 cc off the device and placed the device in manual control with water temperature at 40c.Water temperature immediately went to 38c, and nurse disabled manual mode.Now the patient temperature was 33.8c and water temperature was 37c.

• Brand Name: ARCTIC SUN DEVICE
• Type of Device: ARCTIC SUN DEVICE
• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13434146
• MDR Text Key: 286167150
• Report Number: 1018233-2022-00347
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741161513
• UDI-Public: (01)00801741161513
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60000000
• Device Catalogue Number: 60000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other