Terumo has received the device for evaluation; however, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.For this reason, terumo references evaluation conclusion code (b)(4).Results code: results pending completion of investigation.Conclusions code: conclusion not yet available.
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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 7, 2018.(b)(4).The returned sample was visually inspected.It was noted to contain dried buffer within the threads of the large bore cap.The returned sample was then leak tested (as received) by connecting with the calibrated manometer, submerged into a water bath, and pressurized up to 1030 mmhg.No leak was noted.The large blue cap was attempted to be loosened; however, the dried buffer that remained within the threads, left the large bore cap unable to be loosened.The unit was left to soak in di water for 24 hours.The large bore adapter blue cap was then able to loosened and re-tightened by hand.The sample was then leak tested a second time by connecting with the calibrated manometer, submerged into a water bath, and pressurized up to 1030 mmhg, and no leaks were noted.A retention sample from the same lot number was visually inspected and confirmed to have no traces of buffer on the outside of the unit or inside the pouch.The retention sample was then pressurized with air up to 1030 mmhg, submerged in a water bath, and observed for any leaks.No leaks were noted on the retention sample.The 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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