The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during set-up, air entrainment through venous tube was observed.The unit could not maintain a continuous fluid column after flow stopped.No patient involvement.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 december 18, 2019.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added exp date); g4 (date received by manufacturer); g7 (indication that this is a follow-up report); h2 (follow-up due to additional information); h4 (device manufacture date); h6 (identification of evaluation codes (11, 4114, 3331, 3259, 4307).Method code #1: 11 - testing of device from same lot/batch retained by manufacturer.Method code #2: 4114 - device not returned.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 not returned for investigation.However, based on similar complaints, this was investigated as being an issue with a mis-seated small o-ring that provides the air seal between the curved venous inlet port and the reservoir lid.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.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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