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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 Problems Insufficient Heating (1287); Insufficient Flow or Under Infusion (2182)
Patient Problems Alteration In Body Temperature (2682); Patient Problem/Medical Problem (2688)
Event Type  Injury  
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed.
 
Event Description
It was reported that the patient was not heating on the arctic sun device and having issues with the rewarming. The water was at 5c so the nurse adjusted the low water limit to 20c, but the water was still not warming. The nurse noticed that the patient temperature dropped from 34. 7c to 34. 1c. The target temperature was 37c, the patient temperature was 34. 1c, and the flow rate was 2. 1 l/min. Rewarm reads from 34. 9c at 0. 25c/hour to 37c. The system diagnostics shows that the water level was 5, outlet monitor temperature (t1) was 21. 8c,outlet control temperature(t2) was 21. 7c, and the chiller temperature (t4) was 4. 4c. They drained 500ml of water from the device. The water temperature increased to 30. 4c. The patient temperature was 34c and the flow rate was 2. 4 l/min. The nurse gave a paralytic shortly before the patient temperature dropped because the patient was shivering. 3 hours later, the patient was 36. 2c. A bair hugger was in place. The nurse stated the patient had aspiration pneumonia and that would follow their drug protocol and call back if further assistance needed. One hour later, the patient temperature was 36. 7c. The trend was 2 arrows up, water temperature was 9. 8c, and the flow rate was 1. 8l/min. Rewarm reads from 35. 7c at 0. 25c/hr to 37c. The nurse would not see or feel any signs of shivering. Ms&s discussed the importance of slow rewarm and follows the drug protocol for the heat generation. The nurse stated it was the time for tylenol to administer for paralytic. Per follow-up information received on 28aug2020, the nurse stated that the patient completed the therapy. The patient administered nimbex and tylenol. Nimbex administered for the movement and the other medications administered for the infection.
 
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Brand NameARCTIC SUN 5000
Type of DeviceARCTIC 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 Key10543315
MDR Text Key207308198
Report Number1018233-2020-05968
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161602
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2020
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2015
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: 09/16/2020 Patient Sequence Number: 1
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