This report is being filed to provide additional information in b.5, h.6 and h.11.Investigation: the customer would like the run data file investigated to determine a possible cause for the elevated white blood cell (wbc) content in the platelet product.The lrs chamber has a fixed volume and therefore holds a fixed number of white blood cells for a given chamber flow.On infrequent occasions, this holding capacity may be exceeded, causing higher than expected white blood cell content within the product.This may result in a collected product with greater than expected wbc count.The trima machine may give a message to verify the wbc content in the product or may provide no message to the operator depending on the circumstances.Root cause: there are various reasons for elevated wbc levels in collected product such as donor factors, kit misloads, airblocks, disposable set deviations, paused centrifuge, or other processing difficulty in maintaining the steady state necessary to efficiently separate blood components.Regarding donor factors, there appears to be patterns with repeat donors that produce platelet products with high wbc counts.Saturation events leading to elevated wbcs in collected product are also possible if the donor pre-counts are entered falsely much lower than actual as this can cause the lrs chamber to fill before the system expects and wbcs to escape before detection.Misloading of a set or disposable set deviation may cause a plasma line occlusion or an air block within the centrifuge which may lead to the white blood cells getting flushed out of the lrs chamber into the product.
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