The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, observed blood clot in reservoir of oxygenator.It is still unknown if the event result in delay, if the product was changed out, if the surgery was completed successfully and if there was a blood loss.Terumo continues an attempt to gain more information regarding this event from the user facility.
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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 12, 2022.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 (device evaluated by manufacturer) h4 (device manufacture date) h6 (identification of evaluation codes 10, 11, 3331, 213, 4315) type of investigation #1: 10 - testing of actual/suspected device type of investigation #2: 11 - testing of device from same lot/batch retained by manufacturer type of investigation #3: 3331 - analysis of production records investigation findings: 213 - no device problem found investigation conclusions: 4315 - cause not established the affected sample was inspected upon receipt with slight clotting noted on the outside of the cr filter.The sample was tested for clotting with bovine blood at 5 l/minute for 1.5 hours with no clotting on the filter observed in the cardiotomy portion of the reservoir.The representative retention sample from the same lot number was tested for clotting, no clotting was observed.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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