Terumo has received the device for evaluation; however, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.For this reason, terumo references evaluation conclusion code 11. h3: 81 - evaluation is in progress, but not yet concluded.
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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 04, 2024.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added exp date) g3 (date received by manufacturer) g6 (indication that this is a follow-up report) h2 (follow-up due to additional information and device evaluation) h3 (updated device evaluated by manufacturer) h4 (device manufacture date) h6 (identification of evaluation codes 10, 3331, 213, 67) the affected sample was inspected upon receipt with no anomalies noted.The sample was set up for the vr defoaming testing.The vr defoaming test was set up and blood was flowed through the venous port at 7 lpm with air introduced at approximately 100ml/min.The unit was observed for foaming for 1 hour.There was no foaming observed.The sample was then set up for the cr defoaming testing.The cr defoaming test was set up and blood was flowed through the suction ports at 5 lpm with air introduced approximately 100ml/min.The unit was observed for foaming for 1 hour.There was no foaming observed.The unit was found to function as intended; therefore, a definitive root cause could not be determined.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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