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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 Overfill (2404); Device Sensing Problem (2917)
Patient Problems No Consequences Or Impact To Patient (2199); Shaking/Tremors (2515)
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 had been rewarming for 8 hours and had not reached the target temperature. The patient started rewarming at 33. 3c and was now at 34. 5c. The water temperature was 25. 4c, the flow rate was 2. 9lpm and there was a good fit to the pads. The trend indicator showed one arrow down. The patient had been administered nimbex. The nurse stated that she increased the rewarm rate and the water temperature was appropriately adjusted. She then lowered it back to 0. 3c/hr and the rewarm from read from 34. 5c to 37c at 0. 3c/hr. The water level was 5 and it was explained how overfilling the device can lead to the water heating slowly. The nurse stated that no water was added and she did not want to drain any water. A call back was made two hours later and the patient's temperature was 35. 2c and the water temperature was 32c. The nurse drained 500ml from the right drain port. Another follow up call was made two hours later and the nurse stated that the nimbex was stopped once the patient's temperature began to rise. The patient was now 37c and the patient was shivering again. The water temperature was 9c. The patient received demerol for the shivering.
 
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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 Key8236236
MDR Text Key132778669
Report Number1018233-2019-00219
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number50000000
Device Catalogue Number50000000
Device Lot NumberN/A
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 Received02/04/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/12/2015
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: 01/10/2019 Patient Sequence Number: 1
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