The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, there was leak in the shell at the level of the membrane.Per subsidiary, the problem occur during the installation /priming of the circuit.The patient was not connected to the circuit, water was mainly in the circuit.No patient involvement.There was 20 minutes of delay in the procedure.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 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, 3259, 4307).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: 3259 - improper physical structure.Investigation conclusions: 4307 - cause traced to component failure.The affected sample was not returned; however, pictures were provided, confirming that the blood inlet port was broken off.A representative retention samples were inspected for damage with no damage noted on the device specifically with the blood inlet ports.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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