(b)(6).Manufacturing site evaluation: the shunt system was manufactured by a qualified employee; deviations during assembly did not occur.All parameters have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specifications.Investigation - the shunt system was received dry; it was connected to a paedigav valve (reported separately).No significant deformations or damage of the valves were detected during the visual inspection.It was noted that the ventricular catheter was not properly connected to the control reservoir.Permeability test- this test has shown that the valve has a blockage and that the catheter was permeable.Additionally, the control reservoir was able to be pumped and filled with liquid and then drain the liquid as well.Adjustment test - this has shown that the valve was adjustable to all specified pressures.Braking force and brake function test - this has shown that the brake function is fully operational and the braking force is within the given tolerances.Results - it should be noted that the shunt system was received dry.The investigation of dry items is not significant due to the affect dry deposits of liquor and blood can have on product performance.In spite of this, we have investigated the shunt system to the best of our abilities.After the tests, we have dismantled the valves.Inside, we found a slight build-up of substances (likely protein).Based on our investigations, we confirm the presence of occlusion in the system at the time of investigation.This is likely due to the deposits observed inside the valves.As described in our literature, the problem encountered is one of the known, inevitable risks of hydrocephalus therapy by shunt implants.We can exclude a defect at the time of release.The shunt system met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.
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