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

Model Number 50000000

Device Problems Insufficient Flow or Under Infusion (2182); Gas Leak (2946)

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

Event Type  malfunction  

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 arctic sun device was getting low flow. The nurse stated they did not have a rectal probe, so they were using a foley. The connector for the foley probe was on the as2000, so they were using that instead. Per troubleshooting with ms&s, the nurse was advised that he could use the same cable in the as5000. He stated he would swap the device to the as5000. After swapping the device, the flow rate was 1. 3l/min. The nurse was then instructed to disconnect and reconnect the pads using the proper technique. There was no improvement in flow. The nurse took off the fluid delivery line and ran diagnostics. The flow rate was optimal, inlet pressure was in the -8psi range , and the circulation pump command was in the 60% range. The pads were reconnected one by one and the flow rate was optimal. Hypothermia therapy was restarted, and the flow rate settled at 2. 8l/min.

• Brand Name: ARCTIC SUN 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: 9079892
• MDR Text Key: 193658281
• Report Number: 1018233-2019-05720
• 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: 10/08/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/17/2019
• 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: 10/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse