The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during out of box, they received an incorrect product.As per user facility, they received 3cx*fx25rwc labeled with lot 2m03 but line 23 of the invoice shows lot 2m10.No patient involvement.
|
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 december 16, 2022.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added exp date).G3 (date received by manufacturer).G6 (indication that this is a follow-up report).H2 (follow-up due to additional information).H4 (device manufacture date).H6 (identification of evaluation codes 3331, 4114, 4246, 4308).Type of investigation #2: 3331 - analysis of production records.Type of investigation #3: 4114 - device not returned.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 this incident to the appropriate distribution center for their notification.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
|