The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, they noticed that when the pump air is stopped, it comes back into the venous line.No patient involvement as this occurred during prime.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 april 7, 2020.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 10, 11, 3331, 3259, 4307).Method code #1: 10 - testing of actual/suspected device.Method code #2: 11 - testing of device from same lot/batch retained by manufacturer.Method code #3: 3331 - analysis of production records.Results code: 3259 - improper physical structure.Conclusions code: 4307 - cause traced to component failure.The affected sample was disassembled and found that the small o-ring on the venous inlet had been misseated.A representative retention sample was inspected and tested to confirm an appropriately seated o-ring.The retention sample was setup in a water circuit with flow through the unit, when forward flow was stopped, prime was not lost in the circuit.The cause of the event is a partially seated o-ring within the curved venous inlet port connection into the venous reservoir lid/housing.The o-ring creates an air-tight seal.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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