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 19, 2021.Upon further investigation of the reported event, the following information is new and/or changed: g6 (indication that this is a follow-up report).H2 (follow-up due to additional information and device evaluation).H6 (identification of evaluation codes 10, 11, 3331, 3259, 4307).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 finding #: 3259 - improper physical structure.Investigation conclusions: 4307 - cause traced to component failure.The affected samples were inspected upon receipt to show no visual anomalies.The thermistors on the sample were checked for functionality.It was found that two of the samples did not return a value.Representative retention samples were subjected to multiple sterilization cycles and environmental conditioning cycles and maintained thermistor functionality.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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