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 2, 2020.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).H4 (device manufacture date).H6 (identification of evaluation codes 11, 3331, 4114, 3221, 4315).Method code #1: 11 - testing of device from same lot/batch retained by manufacturer.Method code #2: 3331 - analysis of production records.Method code #3: 4114 - device not returned.Results code: 3221 - no findings available.Conclusions code: 4315 - cause not established.The affected sample was not returned; therefore, a thorough investigation could not be conducted.A representative retention sample was reviewed and water was able to be passed through the manifold assembly without issue.All capiox manifolds are 100% leak tested, ensuring flow through the assembly, during production.All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.
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