The user facility reported to terumo cardiovascular that during prime, there were air bubbles out through the arterial outlet, this coincided with the closure of the larger recirculation.No patient involvement.Product was changed out.Delay was unknown.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 october 27, 2017.The returned sample was visually inspected.A scratch was found on the blood outlet port.No other anomaly was noted on the reminder of the device.The investigation result verified that the actual sample was the normal product with no anomaly related to air entrainment.It is assumable, as a cause of this complaint, that abrupt decrease in the flow rate generated by clamping the circulation led the pressure inside the actual oxygenator to be negative, resulting in air entrainment into the oxygenator.As a cause of the pressure inside the oxygenator having been negative, it is likely that the flow of the prime into the oxygenator was cut off due to the application of clamping while the prime inside the oxygenator was still flowing out of the oxygenator by inertial force.From the available information, however, it is difficult to determine the cause of this complaint definitely.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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