The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, when the shunt sensor was unpacked, a leak was found but priming was performed causing the priming solution to leak.No patient involvement as this occurred during setup.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 september 7,2018.(b)(4).Two samples were returned and visually inspected, no anomalies were noted with either sample.The samples were numbered 1 and 2.Sample 1 was leak tested (as received) by connecting with the calibrated manometer, submerged into a water bath, and pressurized up to 1030 mmhg, and no leaks were noted.The large blue cap was then loosened and retightened by hand.The unit was then pressurized with air, submerged into a water bath, and pressurized up to 1030 mmhg, and no leaks were noted.The large blue cap was again loosened and retightened with a calibrated torque wrench to production specification.The unit was then pressurized with air, submerged into a water bath, and pressurized up to 1030 mmhg, and no leaks were noted.Sample 2 was then leak tested (as received) by connecting with the calibrated manometer, submerged into a water bath, and pressurized up to 1030 mmhg, and no leaks were noted.The large blue cap was then loosened and retightened with a calibrated torque wrench to production specification.The unit was then pressurized with air, 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, submerged in a water bath, and observed for any leaks.No leaks were noted on the retention sample.The complaint was not confirmed, and a definitive root cause was not able to be determined.It is possible that the buffer solution was not completely wiped off the product after buffer fill during manufacturing.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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