The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, the venous probe was not attached to the venous inlet and was found inside the header bag.No patient involvement as this occurred during setup.The product was changed out.The surgery was completed successfully.
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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 december 2, 2020.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added expiration date) g4 (date received by manufacturer) g7 (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, 11, 3331, 3259, 4307) method code #1: 10 - testing of actual/suspected device method code #2: 11 - testing of device from same lot/batch retained by manufacturer method code #3: 3331 - analysis of production records results code: 3259 - improper physical structure conclusions code: 4307 - cause traced to component failure the returned complaint sample was investigated and found to have a broken venous temperature probe.A representative retention sample from the same lot number was inspected and found to be free of damage.Upon review of the complaint sample the temperature probe was found to be damaged.All capiox units are 100% visually inspected at several points in the production process.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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