This report is being filed to provide additional information in h.6 and h.10 and corrected information in b.2, b.3.Investigation: the device history records (dhr) were reviewed for this lot.There were no events noted in the dhr that would have contributed to the elevated wbc count experienced by the customer.The trima accel device has software algorithms that use the rbc detector output to monitor and flag if rbc contamination occurs during pas addition.Run data file analysis showed these algorithms were triggered due to the presence of rbcs at the rbc detector during the pas addition process, leading to the ¿channel line clamp error¿ and ¿pas prime error¿ alerts.The ¿channel line clamp error¿ alerts notified the operator to verify proper closure of the channel line clamps.If these clamps are not fully occluding the channel lines, fluid from the channel containing rbcs and/or wbcs is pulled up and can enter the platelet product bags.Therefore, the platelet product is flagged for wbc content verification, as was the case in this procedure.Signals from the rbc detector showed the cassette was not effectively cleaned during the pas priming process, contributing to the presence of rbcs at the rbc detector during the pas addition process.Possible causes for this failure include, but are not limited to: platelet and/or plasma channel line clamps may not have been fully occluding the channel lines inadequate pas fluid connection, causing any rbc contents within the cassette to enter the platelet product bags.Incorrectly primed filter on the pas line pas bag frangible not broken correctly or reseated ¿ yellow clamp on the pas line not opened fully no further reporting will be provided as this does not represent a reportable event.It was confirmed that the trima machine operated as intended by flagging the product to verify wbcs.
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