The lot complaint history was reviewed, this is the third complaint for the finish goods lot; however, the first for this issue.The device history shows the product was released per specifications.The wet returned sample was visually inspected and no obvious defects were observed.A pressure leak test was performed on the cassette using an external pressure source and no leakage was observed.The root cause for this event in unknown.The presence of fluid leaking from the cassette was not confirmed.After both leakage and console laboratory testing, inspection of the sample indicated no signs of continued leakage from the pump elastomer or cassette.Furthermore, there were no signs of fluid leakage onto the fluidics console due to leakage from the cassette.The cassette passed functional and performance testing.(b)(4).
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