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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 No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/04/2021
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 patient was not rewarming. Patient temperature was 34. 6c, target temperature was 37c, water temperature was 15. 6c, flow rate was 2. 8 l/m. They denied any alerts or alarms. Patient was not on continuous renal replacement therapy. Good pad coverage with no exposed abdomen. Tdi 4 bars trending downward. Patient on continuous drip of fentanyl and versed. Also receiving vasopressors. Mss walked through placing device in manual control at 42c. T1 was 29. 6c, t2 was 29. 6c, t3 was 26. 5c, t4 was 4. 8c. Water flow rate was 3. 0 l/m. Inlet pressure was -6. 9psi. Circulation pump command was 68%. Mixing pump command was 0%. Heater was 100%. System hours were 3492. 2, pump hours were 3292. 9. They disabled manual control and drained water from right drain port. Water rose to 31. 7c, patient temperature was 34. 3c, flow rate was 2. 7 l/m and tdi now only 3 bars trending downward. Doctor discussed adding blankets to head, hands and feet or bair hugger. Doctor called back at 12:39pm et. Patient temperature was 33. 9c and water temperature was 37. 6c. Docter had drain more water off of the right drain port. They increased high water limit from 40c to 42c. Water temperature was 37. 6c and flow rate was 3. 2 l/m. Doctor advised again to add blankets or bair hugger and increase room temp.
 
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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 Key11895693
MDR Text Key257486388
Report Number1018233-2021-03072
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,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/27/2021
Is this an Adverse Event Report? Yes
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 Received08/18/2021
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

Patient Treatment Data
Date Received: 05/27/2021 Patient Sequence Number: 1
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