The certas valve was returned for evaluation.Failure analysis: the position of the cam when valve was received was at setting 2.The valve was visually inspected; needle holes in the needle chamber were noted and marks in the proximal connector were also noted.The valve was hydrate.The catheter was irrigated, no occlusions noted.The valve was leak tested and only leaked from the needle hole in the needle chamber.The valve passed the test for programming, occlusion, reflux, siphon guard and pressure.No root cause could be determined as the technician could not confirm any problem with the valve at the time of investigation.The root cause for the marks in the proximal connector noted during investigation are probably due to using unshod forceps.These marks did not influence the functioning of the valve.The possible root cause for the issue reported by the customer could be due to biological debris and protein build up interfering with the valve mechanism, at the time of investigation the no functional issues were noted with the valve.
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