(b)(4).Upon completion of the investigation it was noted that the position of the cam when valve was received was at setting 5.The valve was visually inspected: some floating biological debris was noted inside the valve.The valve was hydrated.The valve was tested for programming.The valve passed the test.The valve was flushed, the valve passed the test no occlusion was noted.The valve was leak tested, no leaks were noted.The valve was reflux tested.The valve passed the test.The siphon guard was tested.The valve passed the test.The valve was dried.The siphon guard was removed.The valve was then pressure tested, the valve passed the test.Review of the history device records confirmed the valve product code 82-8801pl with lot 122332, conformed to the specifications when released to stock on the 6th march 2017.No root cause could be determined as the problem reported by the customer was not confirmed.The problem was likely due to an excessive flow rate (>0.75 ml/min) during the flushing procedure activates the siphon guard and creates the impression that the valve is distally occluded, this however could not be determined.In reality, the flow is being diverted to the high resistance secondary pathway, this will slow the rate at which csf is shunted from the brain.It would probably explain the problem encountered by the customer.Based on the results of this investigation no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.
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