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

Catalog Number 5000-01-01

Device Problems Insufficient Cooling (1130); Pumping Problem (3016)

Patient Problem Hyperthermia (1909)

Event Date 11/18/2020

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 showed an error 103 (unable to communicate setting) and the water would not drop in the temperature when a one-year-old child was treated to manage the fever using an arctic sun device in the pediatric intensive care unit. While the normothermia therapy has been in place for several hours without a problem and was allowed the patient to be monitored at a target temperature of 37 °c, the arctic sun device was unable to cool the water temperature in order to continue to control the patient's temperature. Therefore, the water temperature remained at room temperature and allowed the patient to return to hyperthermia. Per follow up via ibc on 01dec2020, they delivered other arctic sun device in the icu to treat the patient and completed the therapy. The patient developed hyperthermia because the device had the issue. The icu team used the ice packs while waited for the new console.

• Brand Name: ARCTIC SUN 5000
• Type of Device: ARCTIC SUN DEVICE
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer (Section G): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 11000113
• MDR Text Key: 221278005
• Report Number: 1018233-2020-21646
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 5000-01-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• 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: 12/13/2020 Patient Sequence Number: 1