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

Model Number 50000000

Device Problems Insufficient Cooling (1130); Display or Visual Feedback Problem (1184); Defective Component (2292); Temperature Problem (3022)

Patient Problems Bradycardia (1751); Death (1802); Alteration In Body Temperature (2682); Patient Problem/Medical Problem (2688)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. Device evaluated by mfr: the device was not returned.

Event Description

It was reported that a patient was insufficiently cooling while receiving therapy on the arctic sun device, sn# (b)(4), on (b)(6) 2019. The patient was placed on the arctic sun device following a code event while waiting for a procedure. The patient¿s temperature was 34. 8c while the target temperature was 33c. The water temperature was 30c and the flow rate was 2. 2l/min with a large set of pads and a universal pad. It was confirmed that there was an alert 113 (reduced water temperature control). The (b)(6) female patient was transferred to another icu floor in order to be put on a different arctic sun device. The patient was placed on arctic sun device sn# (b)(4), while arctic sun device sn# (b)(4) was sent to biomed for evaluation. The patient continued therapy on the second device and was in the rewarming phase when the family decided to put a dnr (do not resuscitate) in place and withdraw care. Before the arctic sun device was removed, the patient¿s heart rate decreased and the patient expired before care could be withdrawn. The cause of death was listed as natural causes on the death certificate. The nurse stated that cause of death was due to the patient¿s condition and was not device related. The patient had been admitted with a rash all over her body and several tests were performed to rule out possible diseases including measles. The patient was maxed out on vasopressors as well as receiving continuous renal replacement therapy.

• Brand Name: ARCTIC SUN 5000
• Type of Device: ARCITCSUN 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: 8579533
• MDR Text Key: 145015968
• Report Number: 1018233-2019-02326
• 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,Followup
• Report Date: 09/09/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/03/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse