The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, an overpressure safety valve, that was being used in the aortic root vent line, leaked on the floor and was shooting blood.There was 30 cc blood loss.Product was changed out.Procedure 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 march 5, 2021.Upon further investigation of the reported event, the following information is new and/or changed: g3 (date received by manufacturer), g6 (indication that this is a follow-up report), h2 (follow-up due to additional information), h6 (identification of evaluation codes 4114, 3221, 4315).Type of investigation code: 4114 - device not returned, investigation findings code: 3221 - no findings available, investigation conclusions code: 4315 - cause not established.The sample was not returned so a direct investigation could not be performed.Ops valves are subject to a 100% leak test, which includes five different tests the units are run through to ensure there are no leaks and both the umbrellas and duckbills are functioning properly.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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