The valve was returned in wet conditions and the valve was adjusted on pressure setting 1 (30 mmh2o).In the state of return, debris were noticed: organic debris inside the valve, near the rotor and the shuttles; little debris inside the valve; in the state of return, obstruction has been underlined: air and alcohol could not both easily flow through the shunt (valve, catheters and reservoir).Functional tests for the initially used pressure setting was not conforming to its specification and unstable (+4 to +33mmh2o).One of the possible reasons is the presence of various debris inside the mechanism of the valve, specifically the organic debris that obstructed.Moreover, by the passage of the material, the debris had to push the ball hard enough to unbalance the spring and increase the pressure.Conclusion: the analysis performed by our quality control department confirmed the obstruction of the shunt and a non-conforming in pressure.
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