MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL PADS ARCTIC GEL PADS

Catalog Number 318-02

Device Problems Inaccurate Flow Rate (1249); Insufficient Flow or Under Infusion (2182); Gas Leak (2946)

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 there was low flow on the arctic sun device. The patient was cooling when the arctic sun device alerted "low flow, air leak" the nurses stopped the blanket, emptied that water, disconnected and reconnected the arctic gel pads then restarted. After a minute, they received the same alert again. The user repeated the troubleshooting 3 times and there was no change. The user found no cracks or issue with the arctic gel pads and stated there was adequate water in the system. The nurse stated their pads have a - and + instead of the blue and white marks, so they tried connecting of all ways to see if it would resolve the issue but it did not. They got a new arctic gel pad and connected it to the same device but they got the same alert. The user got a new machine and connected it to the second set of arctic gel pads and it started to function fine with no alerts and have saved the neonatal pads for return. Per follow-up on 06aug2020, it was reported that the patient completed therapy on the second device.

• Brand Name: ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL PADS
• Type of Device: ARCTIC GEL PADS
• 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: 10454650
• MDR Text Key: 205688195
• Report Number: 1018233-2020-05465
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142702
• 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: 12/30/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 318-02
• Device Lot Number: NGEP0417
• 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: 12/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial