The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, there was leakage near blood inlet port.Per facility, the circuit was primed, after 15 minutes of circulation level in reservoir fell roughly 100ml causing the level alarm to trip.No patient involvement.There was 10 minutes delay in the procedure.The product was changed out.The surgery was completed successfully.
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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 apr 12, 2022.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 4114, 11, 3331, 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 root cause could not be determined.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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