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

Model Number 50000000E

Device Problems Device Alarm System (1012); Device Sensing Problem (2917); Gas Leak (2946); Improper Flow or Infusion (2954)

Patient Problems Hypothermia (1915); No Consequences Or Impact To Patient (2199)

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 there was a device sensing issue on the arctic sun device. Hypothermia patient was cooling on the device and the nurse reported that the device was displaying alert 02. Patient temperature was 36. 7c, water temperature was 6c and flow rate was 1. 6l/min. There was good pad coverage and the target temperature was 36c. With pads attached flow rate was 1. 6l/min, inlet pressure was -7psi and circulation pump was at 48%. Ms&s walked her through disconnecting the pads, straightening out the tubing and reconnecting the pads. Flow rate varied from 1. 4 to 1. 6l/min and back down. The nurse stated she could see large air bubbles in the clear connectors. The patient was shivering and they administered medications. Counter warming was in place. Ms&s advised them to change the pads if the flow rate continued to drop and the patients temperature was not dropping after shivering was controlled. Per follow via phone on (b)(6) 2020, the nurse stated the patient was administered fentanyl, buspar and precedex because of the shivering per hospital protocol. The patient was able to complete therapy on the same device and pads with no further issues and the device would be kept in service.

• Brand Name: ARCTICSUN 5000
• Type of Device: ARCTIC 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: 9753060
• MDR Text Key: 187856844
• Report Number: 1018233-2020-01334
• 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: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• Is this an Adverse Event Report?: Yes
• 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

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2018
• 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: 02/26/2020 Patient Sequence Number: 1