The field service engineer went onsite to gather data on the procedure and discovered the leak occurred on cycle 4, with the total volume reinfused of 625ml during the procedure.The bowl was returned to haemonetics for evaluation.Evaluation of the returned bowl confirmed that a leak did occur in the inner core where the bowl base joins with the outer part of the inner core.This could be the possible cause of the leak at the dynamic seal however, it was not possible to confirm due to the condition of the returned sample.There is nothing at this time that would indicate that the death was related to the machine used.It was mentioned by the customer used another cell saver and a new set was used, to continue the procedure, but no further information was provided.
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The following sections were updated to reflect the results of the device evaluation: b1: product problem checked.The investigation determined the device did malfunction.H6: codes for device, results and conclusion were updated to reflect the investigation.The leak in the bowl could contribute to the error liquid in the centrifuge received by the customer during the procedure.The most likely cause of the leak is a crack in the inner core.However, cause of the device malfunction contributing to the adverse event could not be established based on the available information provided from the customer.
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