The certasa valve (828801) was returned for evaluation.Failure analysis - the position of the cam when valve was received was at setting 6.The valve was visually inspected; needle holes in the needle chamber were noted.The valve was hydrated.The catheters were 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 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 the no occlusion issues were noted with the valve.
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