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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 50000000E
Device Problems Insufficient Heating (1287); Overfill (2404)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/20/2021
Event Type  malfunction  
Event Description
It was reported that the patient was on normothermia therapy mode on the arctic sun device. The target temperature was 36c and the patient temperature was 34. 6c but the nurse was not sure why the patient was not getting to target. Mss verified with nurse that the patient temperature was 34. 6c and the target temperature was 36c in normothermia therapy mode, water temperature was 20. 7c and flow rate was 2. 2lpm. Nurse checked event log and system diagnostics showed an alert 113 (reduced water temperature control) and no other device was available. The water level was 5, outlet monitor temperature (t1) was 21. 8c, outlet control temperature (t2) 21. 8c, inlet temperature (t3) 21. 9, chiller temperature (t4) was 6. 2c, inlet pressure was -6. 9psi, circulation pump command was 62 percentage, mixing pump command was 0 percentage, system hours were 4136, pump hours were 3768. They instructed nurse how to put the device in manual control mode with temperature at 38c and walked through draining 500ml from right drain port. The water temperature was increased to 23. 9 quickly. Also advised that it appeared the device was overfilled and that was working appropriately then and reiterated to nurse that if the water temperature did not continue to rise, or if there were additional 113 alerts to send the device to biomed.
 
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed.
 
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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 Key13128948
MDR Text Key285044975
Report Number1018233-2021-08655
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741127755
UDI-Public(01)00801741127755
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 Number50000000E
Device Catalogue Number50000000E
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/24/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2019
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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