This follow-up report is submitted to fda in accord with applicable regulations and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on november 15, 2018.Upon further investigation of the reported event, the following information is new and/or changed: (b)(4).The sample was not returned for evaluation, therefore a thorough investigation could not be performed.It was verified that the incorrect oxygenator was shipped.It was determined that there is a defined location in the distribution center that includes product on pallets on the floor and the indicated product most likely got intermingled with an incorrect item during picking.There was a failure in procedure execution as the picker did not pick the correct item and the packer nor shipper noted the error during their verification.The identified location of product was not optimal as it is less defined for appropriate segregation.The root cause was the distribution center mixed east and west configured products when receiving and picking orders.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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