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

Model Number 50000000

Device Problems Inaccurate Flow Rate (1249); Insufficient Flow or Under Infusion (2182); Temperature Problem (3022)

Patient Problems No Consequences Or Impact To Patient (2199); Insufficient Information (4580)

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 there was low flow on the arctic sun device. The user was getting a low flow alert but flow was currently at 1. 2 l/m but would fluctuate down to 0. 8 l/m. The neonate was at 33. 2c and the target temperature was 33. 5c. Ms&s disconnected and reconnected the arctic gel pads using proper technique with no improvement in flow. The user had tried flipping connection of +/- and ran diagnostics, then the flow was in 2 l/m range, the inlet pressure was in-9 psi range and the circulation pump command was in 60% range. The user reconnected and flow was back down to 0. 8 l/m. At the end of troubleshooting, the temperature began to fluctuate and became erratic reading 28-32c. Ms&s advised to get another arctic gel device and if still getting low flow and change out the arctic gel pad.

• 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: 10474214
• MDR Text Key: 206106576
• Report Number: 1018233-2020-05589
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/10/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: No
• 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: 01/21/2021
• 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