A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.The three used returned active centurion (cen) fluid management system (fms) in the tray were visually inspected.The drain bags were detached from the drain bag tape on the covers due to saturation.The drain bag tapes were adhered on the cassettes properly.Both irrigation and aspiration luers were intact.A calibrated console was used to test the samples and the fms cassette primed, tuned with the ultrasonic handpiece successfully and could achieve maximum vacuum.No system message was generated.No fluid or air leaks, and no cracks were observed on the connectors that would have contributed to the reported event.The irrigation and aspiration flow rates were measured and found to be within specifications.Fluid flowed from the balanced salt solution bottle to the irrigation and aspiration manifolds and continuously to the cassette housing.No occlusion or obstruction was observed during inspection and functional testing.The root cause of the customer's complaint could not be established as the returned fms cassette was evaluated and met specifications.After investigation of this complaint, it has been determined that this sample functioned per specifications; therefore, no corrective action is required at this time.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.Consumables manufacturing management has been made aware of this complaint through the consumer affairs review meeting.The manufacturer internal reference number is: (b)(4).
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