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 mar 15, 2022.Upon further investigation of the reported event, the following information is new and/or changed: 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 and a definitive root cause could not be determined.A representative retention sample was inspected for damage to the area of the arterial pigtail with no damage noted all capiox units are 100% visually inspected at several points in the production process.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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