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

Model Number 50000000

Device Problems Device Alarm System (1012); Insufficient Cooling (1130)

Patient Problems Seizures (2063); Sepsis (2067); Patient Problem/Medical Problem (2688)

Event Type  Injury  

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 the patient was not cooling on the arctic sun device. There was an alert 52 and an alarm 53. The target temperature was 33c, the patient's temperature was 35. 2, the water temperature was 4. 8c and the flow rate was 1. 6lpm. The patient weighed 80. 9kg, and there was adequate coverage with the pads. The complainant noted that the patient was shivering and seizing and was being worked up for sepsis. She was about to begin a paralytic and the patient was already sedated. Ms&s discussed causes of heat generation and explained the device was responding appropriately. They disconnected and reconnected the pads and the flow rate rose to 1. 8lpm. The water was 4. 8c and the patient's temperature was 35c with the trend showing one arrow down. Ms&s discussed counter warming and to be diligent with skin checks. Per follow up via phone on 16mar2020, the charge nurse stated the issue was resolved. The device was in service and therapy was ongoing with no further issue.

• Brand Name: ARCTIC SUN 5000
• Type of Device: ARCTIS SUN DEVICE
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• Manufacturer (Section G): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 9914052
• MDR Text Key: 188329114
• Report Number: 1018233-2020-02218
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• 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: 05/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2011
• 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: 04/01/2020 Patient Sequence Number: 1