MAUDE Adverse Event Report: MEDIVANCE, INC. ARCTIC SUN 5000; SYSTEM, THERMAL REGULATING

Model Number 50000000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)

Event Date 04/14/2020

Event Type  Injury  

Event Description

Patient noted to have back and thigh wounds with a mixture of superficial and deep partial thickness, and an area of full thickness burn to the left lower back, secondary to use of arctic sun warranting transfer to a burn unit.

Event Description

Patient noted to have back and thigh wounds with a mixture of superficial and deep partial thickness, and an area of full thickness burn to the left lower back, secondary to use of arctic sun warranting transfer to a burn unit.From patient info: the patient is a middle-aged male with a history of epilepsy of unclear etiology, alcohol abuse, frequent history of withdrawal seizures, hypertension, and multiple sclerosis (not on disease modifying therapy), he was transferred to neuro icu due to concern for subclinical status epilepticus.He was found to be covid+.His hospital course was complicated by hypoxic respiratory failure and intractable fevers.He was placed on the arctic sun device to maintain normothermia 4 days later.Therapy was initiated using the arctic sun, however target temperature of 37 degrees celsius was not reached during treatment.The temperature of the patient continued to stay well above target temperature, while the water temperature on the arctic sun stayed low (ranging from 5-12 degrees celsius) for almost three days of treatment.In normal circumstances, the device water temperature will oscillate to maintain the patient's temperature at the desired setting.The device may have dips to colder water temperatures, but will come back up as the patient responds.In this case, the patient never responded to cutaneous temperature management.Skin checks were completed by the nursing team, and blisters were noted to form a week later.Treatment was then terminated the following day.The blisters continued to evolve over the hospital stay resulting in subcutaneous thermal damage from the cold temperatures, and the patient had to be transferred for specialized burn treatments.It is with caution that we utilize cutaneous temperature regulatory management for our covid patients, given the associated risk of microthrombi affecting multiple organs including skin.It is unknown whether the response to cold water temperatures was magnified by the disease process.We strongly urge we maintain vigilance when utilizing arctic sun on covid+ patients for temperature management.

• Brand Name: ARCTIC SUN 5000
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): MEDIVANCE, INC.; 321 south taylor avenue suite 200; louisville CO 80027
• MDR Report Key: 10733049
• MDR Text Key: 213002677
• Report Number: 10733049
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 10/16/2020,06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 50000000
• Device Catalogue Number: 50000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/16/2020
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 19345 DA
• Patient Weight: 94