A physician reported infusion failure occurred during procedure.Intraocular pressure control was not maintained normally during pars plan vitrectomy (ppv).After replacing the infusion tube and the infusion cannula, the problem was resolved, and the procedure was completed.There was no patient harm.
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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.The sample was moldy, and the infusion fluid path was clogged with balanced saline solution crystal.The filters on the cassette were saturated with surgical solution.The sample was tested several times on different days, but failed priming.The system message code appeared on the console screen.Using a syringe to purge the fluid path of the cassette and the manifolds, the same failure occurred.Testing could not be performed due to the wet filters.The cassette was dried and then visually inspected again; no obvious defects were found.An extra infusion manifold and infusion cannula line were returned.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 intraocular pressure (iop) calibration successfully.The infusion pressure using both infusion manifolds were measured at multiple set points and met specifications.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.The sample was able to pass all functional and performance testing.The sample met 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 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.No adverse trends have been observed associated with the reported product and event.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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