Other, other text: returned device was received in good physical condition but the arch height pump tube was low.During testing of the returned samples, they failed accuracy tests.Testing/inspection a review of the manufacturing process for p/n 21-7394-24 l/n 4012767 was conducted by quality engineer on (b)(6)2020, in order to verify that there are no situations or practices that could create the event as described in ?complaint description? section.Other analysis during the manufacturing process, production personnel do a visual inspection before a process (assemble, bond, etc.) to ensure that the material is in perfect shape; also, right after a work station, personnel redo an inspection in order to find any discrepancies.Production personnel perform a 100% visual inspection in order to verify that the pump tube arch height is within tolerance.Production personnel perform an accuracy test to 4 samples at shift start up, the end of every shift, the beginning of every job, the end of every job; or a new lot of materials/components or equipment adjusted.Quality takes a sample of 15 units at an interval of two (2) hours, prior to placing product in bag, in order to: -inspect pump tube uv bond to housing, in order to verify that the pump tube arch height is within tolerance.-verify that the adhesive not be excessive or outside the defined application area.-verify parts are free of damage (scuffs, pinch marks, etc.), cracks, crazing, cuts, or other workmanship defects that can affect assembly function or appearance.-audit the accuracy test is being performed according to the manufacturing procedure.Root cause in order to perform a complete root cause analysis of this failure mode, capa 20capa018 was open on (b)(6)2019.Action taken capa 20capa018 was open on 15-oct-2019 in order to implement corrective actions for this failure mode.
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