The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, a leakage was found from the shunt sensor. 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 jul 24, 2018.(b)(4).The returned unit was visually inspected.No buffer remained in the device, and no other visual anomalies noted.The unit was pressurized with air (as received), submerged in a water bath, and observed for leaks.A leak was noted from the large blue luer cap at approximately 195 mmhg.The large blue luer cap was loosened and retightened with the calibrator torque wrench to production specification.It was then pressurized with air, submerged into a water bath, a leak was noted from the large blue luer cap at approximately 390 mmhg.A retention sample from the same lot number was visually inspected and confirmed to have no buffer traces outside the unit or inside the pouch.The retention sample was pressurized with air, submerged in a water bath, and no leaks were noted.The complaint was confirmed and the root cause for this event is a lack of sealing between the large bore adapter (blue cap) and the shunt sensor body.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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