Model Number 3CX*FX25REC |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
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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 out of box, they received 3cx*fx25rec when they ordered 3cx*fx25rwc.No patient involvement.
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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 26, 2018.(b)(4).All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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Manufacturer Narrative
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This follow-up report is submitted to fda in accord with applicable regulations.(b)(4).The investigation verified that the incorrect oxygenator was shipped.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.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.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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