The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the oxygenator started foaming.As per user facility, they were pumping full maze case and in the last half hour the oxygenator started foaming coming out gas out port.No known impact or consequence to patient.The product was not changed out.Procedure 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 march 11, 2020.H6 (identification of evaluation codes 10, 11, 3331, 213, 67).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: 213 - no device problem found.Conclusions code: 67 - no problem detected.The returned sample was visually inspected with no break or any anomaly that could lead to leak.After having been rinsed and dried, it was then tested for leakage by applying air of 2kgf/cm2 to the blood channel, and in 60 minutes after the start of pressurizing, no leak was observed.Review of the dhr and the incoming inspection record of the involved product/lot number combination confirmed that there were no indications of anomaly in them.The evaluation results verified that the actual sample had no anomaly that could result in the leak.All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.
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