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 april 5, 2023.Upon further investigation of the reported event, the following information is new and/or changed: d3 (updated email address) d4 (additional device information - added exp date) g1(updated contact office- first name, last name, email address, telephone number) g3 (date received by manufacturer) g6 (indication that this is a follow-up report) h2 (follow-up due to correction, additional information and device evaluation) h3 (device evaluated by manufacturer) h4 (device manufacture date) h6 (identification of evaluation codes 10, 11, 3331, 3259, 4307) type of investigation #1: 10 - testing of actual/suspected device type of investigation #2: 11 - testing of device from same lot/batch retained by manufacturer type of investigation #3: 3331 - analysis of production records investigation findings: 3259- improper physical structure investigation conclusions: 4307 - cause traced to component failure the affected sample was inspected upon receipt to confirmed that the pigtail line on the arterial outlet was broken off.A representative retention sample was inspected for damage with no damage noted on the device.All capiox units are 100% visually inspected at several points in the production and packaging processes.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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