Additional information provided in d.9., h.3., h.6., and h.10. 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.No occlusion was observed in the manifolds.The ball in the check valve of the drip chamber moved freely per specification.A calibrated console representing the current software version was used to test the sample.The sample could prime and tune with the ultra sonic hand piece successfully.No anomalies were observed during priming.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 on the pump area of the fluidics module.Cleaning process was able to be performed after functional test had 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 data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
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