Manufacturing and quality control data the progav® shunt system was manufactured by a qualified employee in october 2016.Deviations during assembly did not occur.The product was finally tested as article fv440-t and released for packaging and sterilization as well as sterilized by miethke.The progav® has a normal pressure range of 0 to 20 cmh2o.The parameters of the valve were tested at a flow rate of 5 ml/h or 50 ml/h at set pressures of 0, 5, 10 and 20 cmh2o, and were found to meet specifications.The shuntassistant®has a fixed pressure of 15 cmh2o.The parameters of the valve were tested at a flow rate of 5 ml/h or 50 ml/h at a fixed pressure of 15 cmh2o, and were found to meet range the tolerances.All tested parameters were assessed as meeting specifications.Visual inspection in the first step of our investigation, we performed a visual inspection of the product.We have checked for possible damages, deformations of the housing or other abnormalities.The following observations were made during the visual inspection: - deposits detected, picture 3 - rupture in catheter, picture 4 - ruptured catheter, picture 5 permeability test to check if the progav® shunt system is blocked, we have performed a permeability test on the shunt system.This test is carried out with the product in the horizontal position with a hydrostatic pressure difference of approx.30 cmh2o in the direction of flow.The test showed that the progav® shunt system is permeable.Adjustability test we have investigated whether the progav can be successfully set to each specified pressure setting.Thus indicating whether the valve are fully adjustable within the full range of specified pressure settings ( in increments of 5 cmh2o).The progav® was found to be not fully adjustable to specifications.The shuntassistant® is a fixed pressure valve, therefore the adjustability test is inapplicable.Braking force and brake function test the braking force and brake function test investigates whether the braking function of the adjustable valve(s) is present and how much force must be exerted on the housing to release the rotor to adjust the valve(s) using the integrated magnet of a specific measurement apparatus of braking force.The braking force test indicates that the brake function of the progav® valve is present.Due to the non-adjustability of the valve, as detailed in section 7.5, an investigation of the braking force was not possible.Internal inspection of product in order to verify whether the investigated shunt system was compromised by the known risks of hydrocephalus therapy, e.G.By a build-up of natural substances (protein, blood, or tissue particles) in the cerebrospinal fluid, we have dismantled the shunt system.After dismantling of the valves, some deposits were found in shuntassistant® and clearly in progav®.Results based on our investigation, we are able to substantiate the claim of "fractured catheter".At the time of the investigation, it is not clear to us how the mentioned functional impairment occurred.We can exclude the possibility of a defect at the time of release.Our peritoneal catheters are tested to 100 % elongation.After the elongation, a constant deformation of 7 % is acceptable.All products met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.
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