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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/04/2021

Event Type  Injury  

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 patient was not rewarming. Patient temperature was 34. 6c, target temperature was 37c, water temperature was 15. 6c, flow rate was 2. 8 l/m. They denied any alerts or alarms. Patient was not on continuous renal replacement therapy. Good pad coverage with no exposed abdomen. Tdi 4 bars trending downward. Patient on continuous drip of fentanyl and versed. Also receiving vasopressors. Mss walked through placing device in manual control at 42c. T1 was 29. 6c, t2 was 29. 6c, t3 was 26. 5c, t4 was 4. 8c. Water flow rate was 3. 0 l/m. Inlet pressure was -6. 9psi. Circulation pump command was 68%. Mixing pump command was 0%. Heater was 100%. System hours were 3492. 2, pump hours were 3292. 9. They disabled manual control and drained water from right drain port. Water rose to 31. 7c, patient temperature was 34. 3c, flow rate was 2. 7 l/m and tdi now only 3 bars trending downward. Doctor discussed adding blankets to head, hands and feet or bair hugger. Doctor called back at 12:39pm et. Patient temperature was 33. 9c and water temperature was 37. 6c. Docter had drain more water off of the right drain port. They increased high water limit from 40c to 42c. Water temperature was 37. 6c and flow rate was 3. 2 l/m. Doctor advised again to add blankets or bair hugger and increase room temp.

• 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: 11895693
• MDR Text Key: 257486388
• Report Number: 1018233-2021-03072
• 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: health professional,other,use

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: Yes
• 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

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/18/2021
• 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: 05/27/2021 Patient Sequence Number: 1