His 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 june 25, 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, 11, 3331, 213, 67).Type of investigation: #1: 10 - testing of actual/suspected device type of investigation #1: 11 - testing of device from same lot/batch retained by manufacturer.Type of investigation #2:3331 - analysis of production records.Investigation findings: 213 - no device problem found.Investigation conclusions: 67 - no problem detected.Upon evaluation of the returned sample, it was found to function as intended, and met all of the product specifications.The retention sample was visually inspected with no anomalies noted on the device.Ops valves are subject to a 100% leak test, which includes five different tests the units are run through to ensure there are no leaks and both the umbrellas and duckbills are functioning properly.All ops valves are subjected to a 100% leak test that undergoes 5 separate programs to test that each component in the valve is functioning properly.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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