Investigation: the blood bag set was not returned for evaluation.The manufacturing records, test records, and inspection records were reviewed for abnormalities and none were found.The records regarding the particulate removal rates of the filter membranes were reviewed.All membranes conformed to established specification.Shipping testing was performed on the reserve samples from the reported lot number.There serve samples were also visually examined, and the solution volume and solution composition were tested with no abnormalities noted.All product conformed to the established specification.The reported lot number was evaluated and it was determined that the same incident associated with this event, terumo has not received any reports from other customers regarding wbc count failure against this lot number as of october 28, 2019.Root cause: we reviewed the manufacturing record and the testing and inspection record of the reported lot number; however, we did not find any abnormalities and we were not able to identify the cause of the issue.
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