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

Model Number 50000000L

Device Problems Restricted Flow rate (1248); Failure to Prime (1492); Insufficient Flow or Under Infusion (2182)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

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 the arctic sun device would not primed and displayed low flow alert with the flow rate as zero. The nurse disconnected and reconnected the arctic gel pads and restarted that arctic sun device but the flow rate was a zero. Nurse checked the troubleshooting section which was mentioned to drained off 1000mls of water. The nurse drained 900mls of water then the arctic sun device displayed the alert that the arctic sun device was empty however, the device would not take water. The patient was using 2 large artic gel pad on chest, one arctic gel pad on leg and one universal arctic gel pad on the one leg due to a wound which was not associated with the arctic sun device. Esophageal probe was in place to arctic sun device. Event log showed multiple alarm 05 (water reservoir empty) and alert 07 (empty pads not complete) with the arctic gel pad connected. Had disconnected the arctic gel pad and attempted to fill but the arctic sun device still would not take water. Checked that the fill tube was in the correct position. Advised to get another device. Walked through setting up s/n (b)(4) and starting therapy then the flow rate was settled at 3. 1l/min, water temperature was 25. 5c and patient temperature was at 33c with the target temperature of 33c. Recommended to label the arctic sun device with a note of zero flow and would not fill. Per follow up via charge nurse on 24jul2020 , patient completed therapy using another device. Original device sent to biomed.

• 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: 10380384
• MDR Text Key: 205507157
• Report Number: 1018233-2020-05054
• 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: 02/12/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 50000000L
• Device Catalogue Number: 50000000L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse