Incident: pressure setting of 4 was selected.Pt op was 90-100.The valve was opened after valve confirmed at setting 4.Clinician flushed valve and catheter and felt a 'pop'.When he tested the valve w manometer fluid ran through valve slowing below 40mm.Checking again w manometer there was no slowing of fluid through the valve.It ran straight through.We did no feel comfortable implanting this valve due to questionable function.The second valve was set at 4, flushed and manometer tested.The fluid slowed between 110/120mm so this was working as intended and implanted.Same lot number.No injury, no case delay.
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Upon completion of the investigation it was noted that 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 irrigated with purified water.No occlusion was noted.The valve was dried.The valve was leak tested, no leaks were noted.The valve was tested for programming.The valve passed the test.The valve was then pressure tested, the valve passed the test.Review of the history device records confirmed the valve product code 82-8800pl with lot cthcfh, conformed to the specifications when released to stock on the 3rd july 2015.No root cause could be determined as the problem reported by the customer was not confirmed.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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