The lot complaint history was reviewed.This is the tenth complaint for the finished goods lot; however, this is the first complaint for this issue for this lot.The device history record (dhr) shows the product was released per specifications.The returned sample was visually inspected, and no obvious defects were found.The ball in the drip chamber¿s check valve moved freely, per specification.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 sample could prime, tune, and pass iop calibration successfully.The infusion pressure was measured at multiple set points and met specifications.Toggling the infusion and the fluid/air exchange (fax) modes, fluid and air flowed from the cassette to the infusion line continuously without any bubbles in various settings in all sub modes.The sample was able to pass all functional and performance testing.The sample met the specifications.No system message code was generated during testing.Fluid flowed from the balanced salt solution (bss) bottle to the drain bag without any interfering.No leakage was detected from the pump elastomer or in the pump area of the fluidics module.The cleaning process was able to be performed after the functional test had been completed.The root cause of the customer's complaint could not be established; the returned sample functioned per specifications.After an 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 the data for evidence of adverse trending and take further action as appropriate.The manufacturer internal reference number is: (b)(4).
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