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 customer reported, that the cassette had aspiration failure.The used infusion manifold in the pouch was visually inspected.And no obvious defects were found.The sample was tested in the returned condition with the lab stock constellation combined components using the console.The sample primed and passed intra ocular pressure (iop) calibration successfully.No system message code appeared on the screen.Fluid flowed from the balanced salt solution( bss) bottle to the drain bag without any interfering.No air leak was detected from the infusion air line, during priming process.No message code appeared on the screen.No leakage was found from the pump elastomer or onto the pump area of the fluidics module.Cleaning process was able to be performed after functional test was completed.The sample passed functionality.The root cause of the customer's complaint could not be established, as the returned (fms) fluidics management system 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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