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 returned sample was visually inspected and no obvious defects were found that would contribute to the reported event.The non-invasive flow sensor (nifs) on the cassette housing was in good condition.A calibrated console representing the current software version was used to test the sample.The light emission diode rings on the console turned green as the probe connectors were engaged to the console indicating the proper communication between the probe and the console.The ball in the check valve of the drip chamber moved freely per specification.The sample could prime and pass intra ocular pressure calibration successfully.No anomalies were observed during priming.Toggling the infusion and the fluid/air exchange (f/ax) modes, fluid and air flowed from the cassette to the infusion line continuously without any bubble in various settings in all sub modes.With the infusion control on, fluid flowed from the cassette continuously without generating air to the infusion line.When the fluid/air exchange (f/ax) control was on, only air was introduced from the cassette to the infusion line.The infusion pressure, irrigation, and aspiration rate were all measured at multiple set points throughout the console range and met specifications.No system message code was generated during testing.Fluid flowed from the balanced salt solution bottle to the drain bag without any interfering.No leakage was detected from the pump elastomer or on the pump area of the fluidics module.Cleaning process was able to be performed after functional test had completed.No obstruction within the device was observed during evaluation.We were unable to replicate the customer's experience during laboratory evaluation.The root cause of the customer's complaint could not be established; the returned sample functioned per 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.Based on our current tracking, there are no adverse trends for this reported complaint and lot.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
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