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.
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The chiller has failed and needs to be repaired or replaced (probably the second one).In addition, there may be a new chiller pump and then the whole device has to go through an stk/mtk.Primary wo to this complaint is (b)(4).Per sample evaluation results on (b)(6) 2024, it was reported that the chiller pump was faulty.Slow filling due to clogged fill tube filter.
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The chiller has failed and needs to be repaired or replaced (probably the second one).In addition, there may be a new chiller pump and then the whole device has to go through an stk/mtk.Per sample evaluation results on 04jan2024, it was reported that the chiller pump was faulty.Slow filling due to clogged fill tube filter.
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The reported issue was confirmed.The root cause of the reported issue could not be determined.A potential root cause is inadequate cleaning and maintenance.However, this cannot be confirmed.The device was evaluated upon receipt.Slow filling due to clogged fill tube filter.Replaced fill tube.A device history review is not required as the serial number is unknown.The instructions for use were found adequate and state the following: 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.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 customer service to order internal cleaning solution.For information regarding safe handling please refer to http://www.Medivance.Com/manuals for the cleaning solution sds.To replenish the internal cleaning solution: 1) drain the reservoir.Turn control module power off.Attach the drain line to the two drain valves 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.Do not use cleaning solution that has passed the use by date listed on the bottle.The cleaning solution must be stored inside the uv resistant pouch provided." 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.
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