Visual inspection: during the investigation, some blood residue on the device was determined.Permeability test: a permeability test has shown that m.Blue is permeable.Computer controlled test: to investigate the claim of over- drainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valve is tested in both the horizontal as well as the vertical positions.The results show that the m.Blue is operating within the accepted tolerance in the horizontal position, but not within the specified tolerances in the vertical position.An accelerated outflow of m.Blue in the vertical position could be determined.Adjustment test: the m.Blue valve was tested and is adjustable to all specified pressures.Braking force and brake function test: the brake functionality test has shown that the brake function is fully operational and the braking force is within the given tolerances.Internal inspection: after dismantling of the valve, deposits were found in the m.Blue results: based on our investigation results, we can detect an accelerated outflow at the m.Blue.The deposits visible in the valve may have led to the change in the flow rate.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 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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It was reported that a m.Blue valve (#fx803t) was implanted during a procedure performed on (b)(6) 2023.According to the complainant, the valve showed an over-drainage and adjustment difficulties.The patient underwent a revision procedure performed on (b)(6) 2024.The complainant device has returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 14 years, 1 months weight: 107 kgs height: 179 cm gender: female.
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