The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the centrifugal pump failed.Almost near the end of the case, the centrifugal pump motor stopped working due to what appeared to be a high pressure error.There was no other evidence of a high pressure situation present that would have caused the error.The hand-crank was used to continue pumping the case for approximately 5 minutes while the patient was weaned off bypass.Another attempt was made to restart the centrifugal pump but was unsuccessful.The patient had to undergo chest compressions due to being off cpb for 5 minutes.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 3, 2021.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 10, 11, 3331, 213, 67).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: 67 - no problem detected.The affected sample was inspected upon receipt with no visual anomalies noted.The affected sample and a representative retention sample from the same lot were setup to check flow rates at the outlet of the pump.The samples were tested flow rates that span the pumps rated flow capability across the pumps rpm range.The pump outlet pressure was then measured at the respective flow and speed.When compared to the pump flow chart found within the pump ifu, the affected sample and retention sample performed as expected.The sample was able to achieve appropriate flow rates with no apparent deficiency with the disposable pump.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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