Updated information: patient details (below), product details: serial number section d.Evaluation: the progav 2.0 shuntsystem was manufactured by a qualified employee in may 2017.Deviationa during assembly did not occur.Description of incoming product condition: the shunt system was received dry (not submersed in liquid as suggested).Reason of complaint : suspician of occclusion and under-drainage.Patient information: age - 7 years.Weight - 28 kg.Height - 127 cm.Date of implantation - (b)(6) 2018.Date of removal - (b)(6) 2019.Visual inspection: no significant deformations or damage of the valves were detected during the visual inspection.Permeability test: a permeability test has shown that the progav valve has a blockage and that the shunt assistant is permeable.Adjustment test: the progav 2.0 valve was tested and was notadjustable throughout the normal range.Braking force and brake function text: 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.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.Becaise the progav is not permeable, a computer controlled test was not possible; the shunt assitant operates not within the accepted tolerance.Results: it should be noted that the 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 system to the best of our abilities.Finally, we have dismantled the valves.Inside both valves we have found slight build-up of substances (likely protein).Based on our investigation, we confirm the presence of occlusion in the system, a non-adjustability of the progav, and an over-drainage of the shunt assistant.This is likely due to build-up of protein deposits inside the valves.As described in our literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt impants.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.
|