The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, a leakage was observed at the part connected to the circuit.There was 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 december 17, 2018. (b)(4).The actual sample was not returned for evaluation; therefore, a retention sample from the same lot number was visually inspected.The retention sample was confirmed to have no traces of buffer on the outside of the unit or inside the pouch.It was then pressurized with air up to 1030 mmhg, submerged in a water bath, and observed for any leaks, and no leaks were noted.Without the returned sample, a definitive root cause cannot be determined.The most likely root cause for this event was determined to be the large blue vent cap for shunt sensor was not fully tightened either during setup of the circuit, or after the gas calibration.When the large blue vent cap was loosened, it had not been re-tightened fully prior to use in the line, causing a leak from the cap.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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