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 march 17, 2022.Upon further investigation of the reported event, the following information is new and/or changed: 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 unit was only the manifold with no tubing attached.No visual anomalies were noted with the unit.It was then leak tested with no leaks noted.A representative retention sample was inspected for damage to the l-shaped connectors, no damage/cracks were noted.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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