Review of the dhr could not identify any deviations or nonconformities relevant to the issue.The pump was returned to livanova and it has been investigated.As result of investigation the pump occlusion and eccentricity values were found to be within specification.Haemolysis test was performed simulating worst case conditions for haemolysis formation by comparing the complained pump with other similar devices.Based on investigation results, the claimed pump conforms to the approved functional specification for occlusion and concentricity.No impact on pump safety and performance has been observed during the test.Therefore, a pump malfunction can be excluded.Consequently, there is no likelyhood for this device to contribute to death or serious injury.The involvement of the device in the reported event can be ruled out thus the event has been reassessed as non-reportable.
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