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

Model Number	5000-0101
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after draining the arctic sun device during onsite maintenance, level sensor showed 1 bar and showed that it was not empty.Biomed stated that the tank content was very slimy.Level sensor was replaced, cleaned, installed again and the tank was splashed.This fixed the issue with the water level.Per follow up information received 25feb2022, it was stated that the issue was resolved by technician, level sensor and tank were removed and cleaned to resolve the issue.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Additional 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 inadequate maintenance and cleaning.However, this cannot be confirmed.The device was evaluated upon receipt.Tank content was very slimy.Technician cleaned tank and refilled with fresh water and cleaning solution and this corrected the issue.Tank was splashed.This fixed this issue with the water level.Mtk and stk performed.Functional check revealed no issues.The device did not meet specifications, and was influenced by the reported failure.The device was not in use on a patient.A dhr is not required as the device has undergone previous servicing and therefore the reported event is not manufacturing related.The instructions for use were found adequate and state the following: ''cleaning and maintenance cleaning and maintenance routine cleaning and preventive maintenance should be performed on the arctic sun® temperature management system control module every 6 months at a minimum.This consists of cleaning the external surfaces, accessories and chiller condenser, inspecting the device, and replenishing the internal cleaning solution that suppresses microorganism growth in the water reservoir and hydraulic circuit.See the arctic sun® temperature management system service manual for additional information.Replenish internal cleaning solution contact medivance customer service to order internal cleaning solution.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 distilled or sterile water.¿ the filling process will automatically stop when the reservoir is full.Continue to replace the bottles of sterile or distilled 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 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.
Event or Problem Description
It was reported that after draining the arctic sun device during onsite maintenance, level sensor showed 1 bar and showed that it was not empty.Biomed stated that the tank content was very slimy.Level sensor was replaced, cleaned, installed again and the tank was splashed.This fixed the issue with the water level.Per follow up information received 25feb2022, it was stated that the issue was resolved by technician, level sensor and tank were removed and cleaned to resolve the issue.

• Brand Name: ARCTIC SUN® 5000
• Common Device Name: 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13796138
• Report Number: 1018233-2022-01377
• Device Sequence Number: 17103100
• Product Code: DWJ
• UDI-Device Identifier: 00840097502083
• UDI-Public: (01)00840097502083
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K161602
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5000-0101
• Device Catalogue Number: 5000-01-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/22/2022
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown