Manufacturing and quality control data the progav®2.0 was manufactured by a qualified employee in august 2015.Deviations during assembly did not occur.The valve was sterilized by miethke and released for shipment after final inspection.The progav®2.0 has a normal pressure range of 0 to 20 cmh2o.The valve was inspected as article fx410t.All parameters have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specifications.Incoming product condition: the valve was received submersed in an unidentified liquid in the provided returnkit.The complaint device was strongly contaminated with bloody liquid and tissue residues.Results testing of contaminated valves are of limited value.The device characteristics may be influenced by the presence of cerebrospinal fluid or blood residues.As previously indicated, the complaint sample was received submerged in a bloody liquid and was contaminated with tissue residue.Subsequently, the device was classified as high risk to staff and for hygiene reasons, a device evaluation was not able to be performed.Therefore, a definitive conclusion regarding the complaint incident was unable to be reached without a physical examination of the complaint device.Although the device was not evaluated, it is possible that protein deposits inside the valve affected the function of the progav®2.0.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hydrocephalus therapy (hc-therapy) by shunt implants.Manufacturing defects at the time of release have been excluded.The shunt system met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.
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