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 november 5, 2018.(b)(4).The returned sample was visually inspected.It was found upon receipt that the purge line tube had been cut, however, this would not have affected oxygen transfer.There was no anomaly such as break in the appearance on the remainders of the device.The actual sample having been rinsed and dried was tested for its o2 transfer and co2 removal performance.Bovine blood was circulated in the oxygenator module and no anomalies were revealed in the gas transfer performance of the actual sample with the obtained values meeting the factory specifications.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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