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 november 29, 2018.(b)(4).All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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This follow-up report is submitted to fda in accord with applicable regulations.(b)(4).The returned sample was visually inspected, without the sparger assembly.It was leak tested (as received) by connecting with the calibrated manometer, submerged into a water bath, pressurized up to 1030 mmhg.A leak was noted at approximately 20 mmhg.The large bore adapter blue cap was then loosened and re-tightened by hand.It was leak tested for the 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 of the pouch.It was also leak tested and pressurized up to 1030 mmhg.No leaks were noted.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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