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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® 5000 ARCTIC SUN DEVICE Back to Search Results
Model Number 50000000
Device Problem Insufficient Cooling (1130)
Patient Problems Skin Discoloration (2074); Chills (2191)
Event Date 02/26/2022
Event Type  Injury  
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 a normothermia patient was cooling on the arctic sun device, since 2:00 pm the previous day. Nurse stated that a covid patient arrived with 40. 5c (105f) fever. And reported that the device was sounding alert 52 (prolonged cold-water exposure). Patient has not reached the 36c target due to severe shivering, front line shivering protocol was initiated with multiple medications for shivering or fever control including buspar, magnesium, acetaminophen, dexmedetomidine and fentanyl. Nurse stated that bair hugger was added for counter warming. Nurse stated that four large pads and one universal pad was in place with good coverage and patient weighs (b)(6). The protocol brought the patients temperature down from 40. 5c (105f) to 37. 5c, however, the water has remained below 10c for many hours and the patient remained above the target temperature. Nurse stated that current patient temperature was 37. 5c, water temperature was 5. 9c and flow rate was 2. 6l/min. Also wanted to make sure if they had missed anything. Nurse did regular skin checks and was concerned about the prolonged cold-water exposure. The skin was intact but mottled under the pads. Doctor didn¿t want to increase the medications. Bladder probe was in place, however, since the patient was anuric the nurse switched to an esophageal probe. Also stated that event log showed three alerts; alert 52 (prolonged cold-water exposure) and alert 116 (patient temperature 1 change not detected) and alarm 117 (patient temperature 1 change not detected). Mss discussed causes of heat generation and alert 52 (prolonged cold-water exposure). Patients electrocardiography was flat, no sign of seizures, no obvious signs of shivering. Doctors believed that covid infection is the cause of heat generation and do not want to increase the medications. Mss recommended the nurse to speak with the patients care team about the prolonged cold-water exposure and mottling under the arctic sun pads. The arctic sun was responding appropriately to the to changes in the patient¿s temperature and has a good flow rate. This issue was patient related.
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Brand NameARCTIC SUN® 5000
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
juan velez
8195 industrial blvd
covington 30014
MDR Report Key13860986
MDR Text Key287681825
Report Number1018233-2022-01489
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741080142
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number50000000
Device Catalogue Number50000000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/06/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2013
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: 03/23/2022 Patient Sequence Number: 1