MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® 5000; ARCTIC SUN DEVICE

Model Number 60000000

Device Problems Insufficient Heating (1287); Use of Device Problem (1670)

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

Event Date 03/14/2022

Event Type  malfunction  

Event Description

It was reported that they received an alarm 113 (reduced water temperature control) on the arctic sun device.The nurse filled machine with pads on.The patient temperature dropped below 33 c to 31.4 c and foley was in place.The water temperature did not increase above 27 c.Mss explained that they most likely overfilled the machine and knocked heater.Mss walked nurse through how to empty 500ml of water and water temperature was 31.4 c.Nurse would call back if any issues.At 12:28 pm, a hypothermia patient was cooling on the new device.The nurse stated that they called about the patient was being too cold and they drained 500 ml of water from the device.The patient was not tolerating 33c, so they wanted them to warm the patient to 36.5c slowly.The patient temperature was 32.8c, water temperature was 33.8c and flow rate was 2.9 lpm.Mss walked the nurse through stopping and cooling and going to the rewarm mode.The device was programmed to rewarm from 33c at 0.25c/hr to 37c.Mss adjusted the rewarm to 36.5c and explained that with this rate it takes 4 hours to warm the patient one degree and restarted therapy under rewarm.

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 they received an alarm 113 (reduced water temperature control) on the arctic sun device.The nurse filled machine with pads on.The patient temperature dropped below 33 c to 31.4 c and foley was in place.The water temperature did not increase above 27 c.Mss explained that they most likely overfilled the machine and knocked heater.Mss walked nurse through how to empty 500ml of water and water temperature was 31.4 c.Nurse would call back if any issues.At 12:28 pm, a hypothermia patient was cooling on the new device.The nurse stated that they called about the patient was being too cold and they drained 500 ml of water from the device.The patient was not tolerating 33c, so they wanted them to warm the patient to 36.5c slowly.The patient temperature was 32.8c, water temperature was 33.8c and flow rate was 2.9 lpm.Mss walked the nurse through stopping and cooling and going to the rewarm mode.The device was programmed to rewarm from 33c at 0.25c/hr to 37c.Mss adjusted the rewarm to 36.5c and explained that with this rate it takes 4 hours to warm the patient one degree and restarted therapy under rewarm.

Manufacturer Narrative

The reported issue was confirmed.The root cause of the reported issue was isolated to tank overfills due to chloramine-t not added to water during periodic change of fluid causing level sensors to not work.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: "fill reservoir approximately four liters of sterile water will be required to fill the reservoir at initial installation.Fill the reservoir with sterile water only.When filling the control module during initial installation or when completely empty, add one vial of arctic sun¿ temperature management system arctic sun cleaning solution to the sterile water.It is recommended to add the vial when filling with the second liter of sterile water.1) from the patient therapy selection screen, select the button next to either normothermia or hypothermia under the new patient heading.Select any pad type to continue.2) from the hypothermia or normothermia therapy screen, press the fill reservoir button.3) the fill reservoir screen will appear.Follow the directions on the screen.4) the filling process will automatically stop when the reservoir is full.Continue to replace the bottles of sterile water until the filling process stops.5) when the fill reservoir process is complete, the screen will close.6) to stop the process early, press the stop button.Note: if the filling cycle is stopped prior to completion, the reservoir will not be full and may requiring filling after fewer patient therapies have been performed.7) press the cancel button to close the screen." 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® 5000
• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14053394
• MDR Text Key: 289013283
• Report Number: 1018233-2022-02142
• 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: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• 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: 09/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2022
• 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