The certas valve (828804) was returned for evaluation.Failure analysis - the position of the cam when valve was received was at setting 1.The valve was visually inspected; the needle guard was raised, and some needle holes were noted in the needle chamber.The valve was hydrate.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, siphon guard and pressure.The needle chamber was dismantled and the needle guard was bent, and glue traces were noted on the needle guard and the silicone base.The root cause for ¿due to possibility of shunt obstruction.¿ as 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 occlusion issues were noted.The root cause for the raised needle guard noted during the investigation is probably due to wrong handling as noted in the ifu: do not fold or bend the valve, folding or bending might cause rupture of the silicone housing, needle guard disc dislodgement or occlusion of the fluid pathway, at the time of the investigation no occlusion issues were noted.
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