(b)(4).Investigation: the customer set up a new (unexpired) kit and continued with the procedure without incident.The elutra operator's manual directs the operator to check the expiration date on the disposable tubing set package, before loading the tubing set.No patient was involved and the product was not used.Terumo bct followed-up with thecustomer regarding the use of the expired set.The customer confirmed that no product was collected.The customer also said he checked his inventory for any other remaining unused expired kits to be discarded.The device history record (dhr) was reviewed for this lot.There were no issues noted in the dhr for this lot.Root cause: root cause was determined to be a user error in which the customer initially attempted to use an expired set.
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