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

Model Number 50000000

Device Problems Device Alarm System (1012); Overheating of Device (1437); Device Sensing Problem (2917)

Patient Problems Cardiac Arrest (1762); Death (1802); Alteration In Body Temperature (2682); Patient Problem/Medical Problem (2688); Multiple Organ Failure (3261)

Event Date 08/12/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed. The device was not returned.

Event Description

It was reported that while receiving therapy on an arctic sun device, the patient overshot target temperature. The target temperature was 33c. The target temperature was reached, but the patient¿s temperature continued to drop and reached 30c. Therapy was initiated at 0020 on (b)(6) 2019 on a (b)(6) year-old male, after a cardiac arrest. The patient weighed (b)(6) lbs. , and four pads were used for therapy. The nurse increased the water limit on the device from 40c to 42c, but the patient¿s temperature did not increase. At 0136 on (b)(6) 2019, ms&s received a call from the facility stating that the device alerted 115 (water temperature too high for too long). Ms&s advised that this was a safety feature of the machine and not a malfunction and reminded that skin assessments should include assessing the skin under the pads. The patient was receiving epinephrine, vasopressin and levophed drips. The nurse reported severe acidosis despite receiving a sodium bicarbonate drip. The physician discussed the patient¿s status with the family, and they decided to withdraw care. The patient expired immediately upon removal of the ventilator at 0941 on (b)(6) 2019. The nurse stated the cause of death was due to the patient¿s condition and not device related. The cause of death was multi-system failure. The patient had been admitted to the hospital with a diagnosis of heat exhaustion two days prior to the cardiac arrest. His medical history included congestive heart failure, chronic obstructive pulmonary disease, diabetes, coronary artery disease, oxygen dependent with tracheostomy, gastro-esophageal reflux disease, hypertension, hyperlipidemia, prostate cancer and neurogenic bladder. Surgical history included multiple orthopedic surgery and mechanical aortic valve replacement.

• Brand Name: ARCTICSUN 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: 8959559
• MDR Text Key: 219854535
• Report Number: 1018233-2019-05314
• 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
• Report Date: 09/20/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/04/2019
• 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: 09/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse