Visual inspection: during the investigation, bloody deposits on the device, scratches and deformations on the outer housing of the valves and a foreign catheter was determined.Permeability test: a permeability test has indicated the m.Blue has a blockage.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 valve is tested in vertical/ or both the horizontal as well as the vertical positions.Because the valve is not permeable, a computer controlled test is not possible.Adjustment test: the m.Blue valve was tested and is not adjustable throughout the normal range.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 valve, deposits were found in m.Blue results: based on our investigation results, we can determine a non-adjustability and a blockage in the valve.The determined deposits and the deformation can be named as the cause for the functional deviation.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 valve 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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