Model Number 3CX*FX25REC |
Device Problem
Installation-Related Problem (2965)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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Terumo has not received the device for evaluation; therefore, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.(b)(4).
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Event Description
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The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, the tubing pack was set up with the wrong oxygenator.No patient involvement.Product was changed out.Procedure was completed successfully.
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Manufacturer Narrative
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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 september 27, 2018.(b)(4).The investigation 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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Search Alerts/Recalls
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