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

Model Number 50000000

Device Problems Insufficient Heating (1287); Device Displays Incorrect Message (2591)

Patient Problems Cardiac Arrest (1762); Death (1802); No Consequences Or Impact To Patient (2199); Alteration In Body Temperature (2682)

Event Date 05/23/2019

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 warming while receiving therapy on the arctic sun device, sn# (b)(4), at 1758 on (b)(6) 2019. The (b)(6) year old female was placed on the arctic sun device following a cardiac arrest with suspected anoxic brain injury. During the rewarming phase, the patients¿ temperature was 31. 7c with a target temperature of 36. 5c. The water temperature was between 36c-40c, the flow rate was 1. 2l/min with five pads, and good coverage was reported. The nurse reported no alarms or alerts and the patient had stable vital signs. Through troubleshooting with the ms&s helpline, it was confirmed that there was an alert 51 (patient temperature 1 below control range, alert 115 (prolonged warm water exposure), and alert 02 (low flow). The nurse advised ms&s that the device would be switched out. During a follow-up phone call on 28may1019, the nurse reported the patient experienced a second cardiac arrest and expired on (b)(6) 2019 at 0220 on the same device. The nurse stated the cause of death was cardiac arrest and not device related. The nurse also stated the neurological condition of the patient prevented her core temperature from rewarming. The device was sent to biomed for evaluation. The patient had a history of drug abuse and was recently diagnosed with cancer and had not started any cancer treatment. She received vasopressors intermittently during her hospitalization.

• Brand Name: ARCTIC SUN 5000
• Type of Device: ARCTIC SUN
• 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: 8693214
• MDR Text Key: 151648242
• Report Number: 1018233-2019-03101
• 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: other,user facility

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/19/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/12/2019
• 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?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse