The hakim valve (823100) was returned for evaluation.Dhr review - the lot history record was reviewed for completeness during the release process to inventory.At that time based on the fact that no discrepancies were noted for the products being accepted, they were released to stock.Failure analysis - the valve was visually inspected; no defects were noted.The position of the cam when valve was received was 90mmh2o.The valve was hydrated.The catheters were irrigated no occlusions noted, a cut in the peritoneal catheter was noted.The valve was leak tested and no leaks noted.The valve passed the test for programming, occlusion, reflux, and pressure.No root cause could be determined as the technician could not confirm any functional problem with the valve at the time of investigation.The root cause for the cut in the peritoneal catheter, could be due to user, as noted in the ifu silicone has a low cut/tear resistance.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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