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

Model Number 50000000E

Device Problem Insufficient Cooling (1130)

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

Event Date 12/16/2021

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 patient was not at target on the arctic sun device and showed an alert 113 (reduced water temperature control). The patient temperature was 37. 3c, target temperature was 37. 0c, water temperature was 25. 6c, flow rate was 2. 0lpm, outlet monitor temperature (t1) was 25. 6c, outlet control temperature (t2) was 25. 6c, inlet temperature (t3) was 26. 4c, chiller temperature (t4) was 3. 7c, inlet pressure was -5. 8psi, circulation pump command was 100 percentage, mixing pump command was 100 percentage, system hours were 2994, pump hours were 2694. Mss walked nurse through putting device into manual control with water temperature set to 10c. Outlet monitor temperature (or) outlet control temperature remained at 26. 0c (or) 25. 9c, chiller temperature was 5. 2c, circulation pump command was 100 percentage, mixing pump command was 100 percentage. Also confirmed that no one had added water to the device and advised the nurse how to disable manual control and to send to biomed tagged with alert 113.

• 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: 13115520
• MDR Text Key: 284527674
• Report Number: 1018233-2021-08554
• Device Sequence Number: 1
• Product Code: DWJ
• 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
• Report Date: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 50000000E
• Device Catalogue Number: 50000000E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 12/29/2021 Patient Sequence Number: 1