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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 ARCTICSUN 5000 ARCTIC SUN DEVICE Back to Search Results
Model Number 50000000E
Device Problems Device Alarm System (1012); Device Sensing Problem (2917); Gas Leak (2946); Improper Flow or Infusion (2954)
Patient Problems Hypothermia (1915); No Consequences Or Impact To Patient (2199)
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 there was a device sensing issue on the arctic sun device. Hypothermia patient was cooling on the device and the nurse reported that the device was displaying alert 02. Patient temperature was 36. 7c, water temperature was 6c and flow rate was 1. 6l/min. There was good pad coverage and the target temperature was 36c. With pads attached flow rate was 1. 6l/min, inlet pressure was -7psi and circulation pump was at 48%. Ms&s walked her through disconnecting the pads, straightening out the tubing and reconnecting the pads. Flow rate varied from 1. 4 to 1. 6l/min and back down. The nurse stated she could see large air bubbles in the clear connectors. The patient was shivering and they administered medications. Counter warming was in place. Ms&s advised them to change the pads if the flow rate continued to drop and the patients temperature was not dropping after shivering was controlled. Per follow via phone on (b)(6) 2020, the nurse stated the patient was administered fentanyl, buspar and precedex because of the shivering per hospital protocol. The patient was able to complete therapy on the same device and pads with no further issues and the device would be kept in service.
 
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Brand NameARCTICSUN 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 Key9753060
MDR Text Key187856844
Report Number1018233-2020-01334
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number50000000E
Device Catalogue Number50000000E
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 Received04/10/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/24/2018
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: 02/26/2020 Patient Sequence Number: 1
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