Aesculap inc.(importer, registration no.2916714) is submitting this report on behalf of christoph miethke gmbh & co.Kg (manufacturer, registration no.3004721439).Exemption number: e2017044.Investigation: visual inspection no significant deformations or damage of the valve were detected during the visual inspection.Permeability test a permeability test has indicated that the valve has a blockage.Adjustment test this is a fixed pressure valve.An adjustment test is not applicable.Braking force and brake function test this is a fixed pressure valve.A braking force and brake function test is not applicable.Computer controlled test to investigate the claim of over/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 both the horizontal as well as the vertical positions.Because the valve is not permeable, a computer controlled test is not possible.Results it should be noted that the paedigav valve was received dry (i.E.Not submersed in liquid as recommended).The investigation of dry items is not significant due to the affect dry deposits of liquid and blood can have on product performance.In spite of this, we have investigated the valve to the best of our abilities.First we performed a visual inspection of the paedigav valve.No significant deformations or damage of the valve were detected during the visual inspection.Next we tested the permeability of the valve.The valve was shown to have a blockage.Due to the non-permeability of the valve the suspicion of underdrainage was unable to be investigated using our computer controlled simulated flow test.Finally, we have dismantled the valve.Inside the valve we have found significant build-up of substances (likely protein).Based on our investigation, we confirm the presence of occlusion in the valve, likely due to the deposits observed inside the valve.As described in our literature, the problem encountered is one of the known, inevitable risk of hc-therapy by shunt implants.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when release from christoph miethke gmbh & co.Kg.
|