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 february 5, 2019. upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added exp date).D10 (device availability - added date returned to manufacturer).G4 (date received by manufacturer).G7 (indication that this is a follow-up report).H2 (follow-up due to additional information and device evaluation).H3 (device evaluated by manufacturer).H4 (device manufacture date).H6 (identification of evaluation codes 10, 11, 3331, 213, 67).Method code #1: 10 - testing of actual/suspected device.Method code #2: 11 - testing of device from same lot/batch retained by manufacturer.Method code #3: 3331 - analysis of production records.Results code: 213 - no device problem found.Conclusions code: 67 - no problem detected.The returned sample was visually inspected and one of the wings was completely broken off of the unit.It was then leak tested (as received) by connecting with the calibrated manometer, submerged into a water bath, and pressurized up to 1030 mmhg.A leak was noted at approximately 6 mmhg.The large bore adapter blue cap was then loosened and retightened by hand.The sample was then leak tested for the second time, 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.It was also leak tested, pressurized up to 1030 mmhg, and 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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