Visual inspection: during the investigation, bloody residue on the outer housing of the valves, but no significant deformations or damage were determined.Permeability test: a permeability test has shown that the m.Blue has a blockage while the progav 2.0 is 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 valves are tested in both the horizontal as well as the vertical position.As the m.Blue is not permeable, a computer-controlled test is not possible.The investigations on the progav 2.0, however, show that the progav 2.0 works within the permissible tolerance in the horizontal position.Adjustment test: during the adjustment test it was determined that both valves are not adjustable in all pressure ranges.Braking force and brake function test: the brake functionality test has shown that the brake function operates as expected; 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 both valves.To make the deposits in the shunt system more visible, they were colored using a staining solution.Results: in advance, we would like to point out that the product sent in was not inserted in liquid at the time of delivery.Dried deposits can influence the function of the products, which can affect the results.Despite this, we have examined the valve.Based on our investigation results, we can determine a blockage on the m.Blue and non-adjustability on both valves.The deposits visible in the valves may have led to the malfunctions at the valves.Deposits caused by natural substances in the body, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.Even small amounts of proteins can impair the integrity of the valve.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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