Investigation: visual inspection: during the investigation, no significant deformations or damage of the valves was determined.Permeability test: a permeability test has indicated that the shunt assistant 2.0 has a blockage and the progav 2.0 valve and the ped.Pre-chamber are permeable.Computer controlled test: to investigate the claim of under-drainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The progav 2.0 valve is tested in the horizontal position.Because the shunt assistant 2.0 is not permeable, a computer controlled test is not possible.Accelerated outflow was detected in the progav 2.0.Adjustment test: the progav 2.0 was tested and is not adjustable.Braking force and brake function test: the brake functionality test has shown that the brake function is operational, however the braking force cannot be measured due to the non-adjustability of the valve.Internal inspection: after dismantling of the valves, deposits were found in progav 2.0 and shunt assistant 2.0.To make the proteins / deposits in the shunt system more visible, they were colored using a staining solution.Results: based on our investigation results, we can determine an accelerated outflow and adjustment difficulties in the progav 2.0.The shunt assistant 2.0 has a blockage.The determined deposits can be named as the cause for these problems.Proteins in the cerebrospinal fluid can influence the function temporarily and are known side effects in hydrocephalus therapy.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.No further regulatory actions are required from our point of view.
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