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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 Inaccurate Flow Rate (1249); Insufficient Information (3190)
Patient Problems No Consequences Or Impact To Patient (2199); Alteration In Body Temperature (2682)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed.
 
Event Description
It was reported by the day nurse that the night nurse switched out the device and pads because they were not functioning properly. The day nurse called to report that the patient overshot the target temperature. The flow rate at the time of the call was 1l/min. Per troubleshooting, the nurse was advised to disconnect and reconnect the pads and to check for kinks and bends. The water level was 4 bars, the patient's temperature was 37. 7c, the target temperature was 37c, the water temperature was 13. 1c, the flow rate was 0. 7l/min, the inlet pressure was -6. 7psi, and the circulation pump command was 32%. The nurse was advised to reconnect the pads. She stopped therapy and emptied the pads. The flow rate was 0. 8l/min, the inlet pressure was -7. 4psi, and the water level was at 1 bar. The nurse was told how to fill the device, but it did not take much fluid and read on the device that it was full. The flow rate was still 0. 9l/min. The nurse was advised to switch out the device. The nurse was called back an hour later, and it was confirmed that the device was switched. Additional information was received from the nurse on 08aug2019. She stated that the patient completed therapy on the third device.
 
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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 Key8923505
MDR Text Key188353347
Report Number1018233-2019-05038
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 other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/25/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/22/2019
Is this an Adverse Event Report? No
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 Received09/23/2019
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

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