Information on a smith medical cadd administration sets - flow stop underinfused.The infuson was to run 250 ml for 46 hours and according to (b)(6) medical center - (b)(6), the patients would return with 15-30 ml remaining ,even when pump read "res vol empty." no patient adverse events reported.Unknown medication to that was infused, however the 250 ml may not account for volume of medication that was inserted into bag.This could account for extra volume.
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One cadd administration sets - flow stop was returned for analysis.The sample was visually inspected at a distance of 12" to 16" under normal conditions of illumination.No discrepancies were detected on the housing nor arch height.The samples were used with the cadd solis pump for accuracy testing and no discrepancies were found.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 ,and verify parts are free of damage (scuffs, pinch marks, etc.), cracks, crazing, cuts, or other workmanship defects that can affect assembly function or appearance.A cause of issue was not determined since the samples passed all testing.
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