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 september 10, 2021.Upon further investigation of the reported event, the following information is new and/or changed: g6 (indication that this is a follow-up report).H2 (follow-up due to additional information and device evaluation).H6 (identification of evaluation codes 10, 11, 3331, 213, 67).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: 213 - no device problem found.Investigation conclusions: 67 - no problem detected.The returned 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.The returned sample was setup to be manually run through each of these tests to determine if the umbrellas were functioning properly and not allowing air to enter the valve.The sample was found to function as intended, and met all of the product specifications.The retention sample was visually inspected with no anomalies noted.It was also manually run through the ops leaks ensure each component of the device is functioning as normal.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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