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

Model Number 60000000

Device Problem Insufficient Cooling (1130)

Patient Problem Chills (2191)

Event Date 01/20/2022

Event Type  malfunction  

Event Description

It was reported that the arctic sun device was getting an alert 117 (patient temperature 1 change not detected), and restarted from force stop. Target temperature was 36c, patient temperature was 37. 5c, flow rate was 2. 9lpm, water temperature was 5. 7c, system hours were 737. 5, pump hours were 651. 2, outlet monitor temperature (t1) was 5. 7c, outlet control temperature (t2) was 5. 7c, inlet temperature was 10. 3c, chiller temperature was 4. 0c, inlet pressure was -7. 5psi (settling after restart), circulation pump command was 79 percent and mixing pump command was 0 percent. Nurse stated that patient was shivering and was not on any sedation. Mss advised that the water returning to the device was much warmer than the water flowing out of the device and discussed heat generation and non- pharmacological interventions such as bair hugger. Mss also discussed on consulting their protocol for shiver management. Nurse had also filled the device without an alert when they got this device. Water level was 5 bars, drained 500ml from the right drain port. 15 minutes later, patient temperature was dropping 36. 9c and water temperature was 5. 8c. No new alerts or alarms noted. Per follow up information received on (b)(6) 2022, nurse stated that therapy was completed successfully with the second arctic sun device. Nurse stated they labeled the first arctic sun device to be picked up by biomed. There was no impact to the patient.

Manufacturer Narrative

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

• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13527922
• MDR Text Key: 288692080
• Report Number: 1018233-2022-00605
• Device Sequence Number: 1
• Product Code: DWJ
• 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

• Type of Report: Initial,Followup
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 60000000
• Device Catalogue Number: 60000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 02/14/2022 Patient Sequence Number: 1