The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during out of box, the incorrect product was received.Fx25rec was ordered but fx25rwc was received.They added that the label was correct but not what was ordered.No patient involvement as this occurred during out of box.
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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 march 19, 2021.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added expiration date) g3 (date received by manufacturer) g6 (indication that this is a follow-up report) h2 (follow-up due to additional information and device evaluation) h3 (device evaluated by manufacturer) h4 (device manufacture date) h6 (identification of evaluation codes 10, 3331, 4246, 4308) type of investigation #1: 10 - testing of actual/suspected device type of investigation #2: 3331 - analysis of production records investigation findings: 4246 - transport/storage problem identified investigation conclusions: 4308 - cause traced to transport/storage the investigation verified that incorrect product was shipped.A supplier notification was sent for a related incident to the distribution center for further investigation.The investigation determined that the associate picked in the right location, but the product on that location was not the correct one.The associate did not note and did not use the right equipment to confirm the pick.For this reason, it is considered associate error.Training was conducted with the responsible associates.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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