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

Catalog Number 5000-01-01

Device Problem Partial Blockage (1065)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2023

Event Type  malfunction  

Event Description

It was reported that the arctic sun device had black screen during the use.Per follow up information received via email on 01aug2023, they confirmed device was sent to bd-approved facility for evaluation.They done repair with filling tube replaced + tests done : fv ¿ ctu calibration ¿ est.No patient impact and no medical intervention required.Per sample evaluation results on (b)(6) 2023, it was reported that the device was unable to fill as the fill tube was clogged.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.

Manufacturer Narrative

The reported issue was confirmed.The root cause of the reported issue could not be determined.A potential root cause is inadequate maintenance.However this cannot be confirmed.Fill tube found to be clogged during service.Fill tube was replaced.Device underwent functional verification, ctu calibration, est and passed all applicable tests.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.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.External surfaces: clean the exterior body of the control module, fluid delivery lines, power cords and temperature cables using a soft cloth and mild detergent or disinfectant according to hospital protocol.Condenser: a dirty chiller condenser will significantly reduce the cooling capacity of the control module.To clean the condenser, wipe the dust from the exterior grill using a soft cloth.Depending on the quality of your institution¿s air, periodically remove the back cover and vacuum or brush the condenser fins.At a minimum the condenser fins should be cleaned annually.Maintenance activities should be performed by qualified personnel.Device inspection periodically inspect the external areas of the device for damaged, loose or missing parts, and frayed or twisted power cords and cables.Discontinue using the device displaying one or more of the above conditions until the problem is corrected and has been verified to be operating correctly.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 Description

It was reported that the arctic sun device had black screen during the use.Per follow up information received via email on 01aug2023, they confirmed device was sent to bd-approved facility for evaluation.They done repair with filling tube replaced + tests done : fv ¿ ctu calibration ¿ est.No patient impact and no medical intervention required.Per sample evaluation results on 18aug2023, it was reported that the device was unable to fill as the fill tube was clogged.

• 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 Key: 17664741
• MDR Text Key: 322499105
• Report Number: 1018233-2023-06473
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K161602
• Number of Events Reported: 1
• 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: 11/16/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 5000-01-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2023
• Initial Date FDA Received: 08/31/2023
• Supplement Dates Manufacturer Received: 11/16/2023
• Supplement Dates FDA Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other