The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, they noticed air bubbles occurring and rising at the venous inlet.Per user facility, they tightened all connections but wasn't able to stop the bubbles.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 may 18, 2020.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added expiration date).G4 (date received by manufacturer).G7 (indication that this is a follow-up report).H2 (follow-up due to additional information and device evaluation).H3 (device evaluated by manufacturer).H4 (device manufacture date).H6 (identification of evaluation codes 10, 11, 3331, 3259, 25) 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: 25 - cause traced to manufacturing.The affected sample was inspected upon receipt with no anomalies noted.It was disassembled where it was found that the small o-ring had been incorrectly installed, allowing the air leak to occur.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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