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 january 18, 2022.Upon further investigation of the reported event, the following information is new and/or changed: b1 (corrected report type - product problem); 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 correction); h4 (device manufacture date); h6 (identification of evaluation codes 11, 3331, 4114, 3221, 4315).Type of investigation #1: 11 - testing of device from same lot/batch retained by manufacturer.Type of investigation #2: 3331 - analysis of production records.Type of investigation #3: 4114 - device not returned.Investigation finding: 3221 - no findings available.Investigation conclusions: 4315 - cause not established.The affected sample was not returned; therefore, a thorough investigation could not be performed.A representative sample was obtained and tested for foaming in the reservoir.No anomalies were noted.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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