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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); Overfill (2404)
Patient Problem Bradycardia (1751)
Event Date 12/20/2021
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 that the nurse stated target temperature was 36. 0 c, patient temperature was currently 35. 3 c in the arctic sun device. Mss wanted to confirm if device was working properly. User confirmed patient temperature was 35. 3 c, target temperature was 36. 0 c, water temperature was 26. 7 c, flow rate was 3. 3 lpm, water level was 5, inlet pressure was -7. 0 psi, circulation pump was 84%, mixing pump was 0%, system hours were 8872, preventive hours were 7070. It stated that there were no alerts or alarms in event log per nurse. Mss put device in manual control with water temperature was set to 40 c, drained 500 ml from right drain port, water temperature rose to 40. 1 c. User disabled manual control. Patient was bradycardic during call and physician ordered rewarming to 37 c while on call. Mss walked caller through restarting therapy in rewarm to 37 c, patient temperature was currently 35. 2 c, water temperature was 38. 3 c, flow rate was 2. 4 lpm. Mss advised caller to call back if any other issues.
 
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Brand NameARCTIC SUN® 5000
Type of DeviceARCTIC SUN DEVICE
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
yonic anderson
8195 industrial blvd
covington 30014
7707846100
MDR Report Key13128590
MDR Text Key286339083
Report Number1018233-2021-08650
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741080142
UDI-Public(01)00801741080142
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,Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2021
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
Date Manufacturer Received05/25/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2012
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: 12/31/2021 Patient Sequence Number: 1
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