The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, there was a constant stream of bubble into the resrvoir all the way from the bottom.No patient involvement as this occurred during prime, product was 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 june 1, 2018.(b)(4).The returned sample was visually inspected.The caps were not present on any ports of the reservoir.The returned sample was connected to a circuit and saline was circulated.It was not able to replicate the reported event as there were no bubbles coming up through the curved venous inlet port upon stopping the centrifugal pump.The reservoir was then opened up and closely inspected the vr filter sock and inside components.The o-ring was found to have a wearing mark, which could present the reported defect.A retention sample from the same part number / lot number was obtained.The retention sample was circulated in the same manner as the returned sample, and no bubbles were noted.Similar markings that were found on the returned sample, were able to be recreated by intentionally pinching the small o-ring in the venous inlet connector and twisting.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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