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 november 1, 2019.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added exp date).G4 (date received by manufacturer).G7 (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, 3259, 4307).Method code #1: 10 - testing of actual/suspected device.Method code #2: 11 - testing of device from same lot/batch retained by manufacturer.Method code #3: 3331 - analysis of production records.Results code: 3259 - improper physical structure.Conclusions code: 4307 - cause traced to component failure.The affected sample was reviewed upon receipt and confirmed damage to the venous inlet port.Retention sample from variety of lot numbers were reviewed with no anomalies noted.The process steps were reviewed and evaluated for improvement opportunities for handling during manufacture.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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