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, 170, 25).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: 170 - manufacturing process problem identified.Investigation conclusions: 25 - cause traced to manufacturing.The actual device was not returned; however, the small piece of foreign material was returned.The foreign material was sent for ftir analysis to be identified as urethane, which is used is used in the cr filter assembly.A representative retention sample was reviewed with no foreign materials within the reservoir.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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