The certas valve was returned for evaluation.Failure analysis - the position of the cam when valve was received was at setting 3.The valve was visually inspected; no defects were noted.The valve was hydrated.The catheter was irrigated no occlusions noted.The valve was leak tested and no leaks noted.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 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 no functional issues were noted.
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