The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during other non clinical activity, an over shipment product was found.As per company representative, "according to our warehouse, physically 1 carton of item 3cx*fx25rec batch 2c07 has been delivered too many.No patient involvement.
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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 august 12, 2022.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added expiration date) e2 (updated health professional) e3 (updated occupation) g3 (date received by manufacturer) g6 (indication that this is a follow-up report) h2 (follow-up due to correction and additional information) h4 (device manufacture date) h6 (identification of evaluation codes 3331, 4114, 3236, 4308) type of investigation #1: 3331 - analysis of production records type of investigation #2: 4114 - device not returned investigation findings: 3236 - transport problem identified investigation conclusions: 4308 - cause traced to transport/storage the investigation verified that incorrect product was shipped.An sncr was sent for this incident to the appropriate distribution center for further investigation.The root cause was the distribution center picked and sent incorrect product.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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