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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); Overheating of Device (1437)
Patient Problems Arrhythmia (1721); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/12/2022
Event Type  Injury  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
 
Event Description
It was reported that the arctic sun device was having issues with heating and has ran over 2000 hours, device would be coming in for the 2000 hour preventive maintenance service.Per additional information received on (b)(6) 2022, there was no patient involvement reported.Device would be sent in for 2000 preventive maintenance and repair.Per additional information received on (b)(6) 2022, it was confirmed there was patient involvement.
 
Event Description
It was reported that the arctic sun device was having issues with heating and has ran over 2000 hours, device would be coming in for the 2000 hour preventive maintenance service.Per additional information received on 19oct2022, there was no patient involvement reported.Device would be sent in for 2000 preventive maintenance and repair.Per additional information received on 19oct2022, it was confirmed there was patient involvement.Per additional information received via email on 03nov2022.Nurse stated the patient was warmed too quickly causing cardiac dysrhythmias, increase in heart rate, and low blood pressures.The patient required a cardizem, digoxin, and lopressor push for recovery due to the malfunction in the arctic sun.The therapy was not completed with this device.The staff utilized another arctic sun to finish the therapy.The patient was a 53 year old female with date of birth (b)(6) 1968.Per sample evaluation results received on 13dec2022, it was reported that the double bend tube and the chiller evaporator outlet tubing appear distended or expanded.The double bend tube and the chiller evaporator outlet tube had both been replaced.
 
Manufacturer Narrative
The reported issue was confirmed.The root cause of the reported issue could not be determined.A potential root cause of the reported issue could be due to an overfill of the device.However, this cannot be confirmed.During evaluation, it was determined to be too much water in the device.T4 (chiller water tank temperature) rose along with the main tank temperature as it heated even though the mixing pump was off.This indicates the two tanks were mixing together.Confirmed heating problem in patient data files dated 10/10/ 2022.In manual normothermia mode a commanded temperature of 40 degrees c was not achieved.Preventatively replaced the level sensor.The double bend tube and the chiller evaporator outlet tubing appears distended/expanded.The device underwent pm servicing while in for repair.Serviced circulation pump and mixing pump replaced heater, double bend tube, and replacing both manifold o-rings and drain valves.The arctic sun 5000 passed all performance testing, calibration and electrical safety tests and is functioning properly and ready for use.The did not meet specifications and was influenced by the reported failure.The device was in use on a device patient.The dhr is not required as this is not an out-of-box failure.Based on the results of the investigation, no additional actions are needed.The instructions for use were found adequate and state the following: "fill reservoir 1) fill the reservoir with sterile water only.2) four liters of water will be required to fill the reservoir at initial installation.3) add one vial of arctic sun® temperature management system cleaning solution to the sterile water.4) from the patient therapy selection screen, press either the normothermia or hypothermia button, under the new patient heading.5) from the hypothermia or normothermia therapy screen, press the fill reservoir button.6) the fill reservoir screen will appear.Follow the directions on the screen.To replenish the internal cleaning solution: 1) drain the reservoir.¿ turn control module power off.¿ attach the drain line to the two drain ports on the back of the control module.Place the end of the drain line into a container.The water will passively drain into the container.2) refill the reservoir.¿ from the hypothermia therapy screen or the normothermia therapy screen, press the fill reservoir button.¿ the fill reservoir screen will appear.Follow the directions on the screen.¿ add one vial of arctic sun® temperature management system cleaning solution to the first bottle of sterile water.¿ the filling process will automatically stop when the reservoir is full.Continue to replace the bottles of sterile water until the filling process stops.¿ when the fill reservoir process is complete, the screen will close." h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the actual/suspected device was inspected.
 
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Brand Name
ARCTIC SUN® 5000
Type of Device
ARCTIC 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
xeeroy rada
8195 industrial blvd
covington 30014
7707846100
MDR Report Key15679461
MDR Text Key306828387
Report Number1018233-2022-08136
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 Physician
Type of Report Initial,Followup
Report Date 03/03/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number50000000E
Device Catalogue Number50000000E
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/12/2022
Initial Date FDA Received10/27/2022
Supplement Dates Manufacturer Received03/03/2023
Supplement Dates FDA Received03/06/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age53 YR
Patient SexFemale
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