The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, when the shunt sensor was being unpacked, buffer solution was found to have leaked.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 july 26, 2018.(b)(4).The returned sample was visually inspected.There was no buffer solution present within the returned device.There were no other anomalies noted.The returned sample was leak tested 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.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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