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

Model Number 50000000

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

Patient Problem Bradycardia (1751)

Event Date 12/20/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress. Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the nurse stated target temperature was 36. 0 c, patient temperature was currently 35. 3 c in the arctic sun device. Mss wanted to confirm if device was working properly. User confirmed patient temperature was 35. 3 c, target temperature was 36. 0 c, water temperature was 26. 7 c, flow rate was 3. 3 lpm, water level was 5, inlet pressure was -7. 0 psi, circulation pump was 84%, mixing pump was 0%, system hours were 8872, preventive hours were 7070. It stated that there were no alerts or alarms in event log per nurse. Mss put device in manual control with water temperature was set to 40 c, drained 500 ml from right drain port, water temperature rose to 40. 1 c. User disabled manual control. Patient was bradycardic during call and physician ordered rewarming to 37 c while on call. Mss walked caller through restarting therapy in rewarm to 37 c, patient temperature was currently 35. 2 c, water temperature was 38. 3 c, flow rate was 2. 4 lpm. Mss advised caller to call back if any other issues.

• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13128590
• Report Number: 1018233-2021-08650
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741080142
• UDI-Public: (01)00801741080142
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161602
• 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: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 50000000
• Device Catalogue Number: 50000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sex: No Answer Provided
• Patient Weight: KG
• Patient Outcome(s): Other