The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, there was leakage found in the vent luer adapter.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 30, 2018.(b)(4).There were four total samples returned.Sample 3 and 4 were lot for this complaint.The returned samples were visually inspected.Sample 3 contained a normal production level of buffer solution.Sample 4 had a small amount of buffer solution remaining in the unit.The returned samples were then leak tested individually upon receipt by connecting with the calibrated manometer, submerged into a water bath, and pressurized.Both samples did not leak while being pressurized up to 1030mmhg.The large bore adapter blue cap was then loosened and re-tightened on each sample with a calibrated torque wrench to production specification as these leaks were all reported during unpacking.The samples were then leak tested a second time by connecting with the calibrated manometer, submerged into a water bath, and pressurized.Sample 3 did not leak while being pressurized up to 1030mmhg.A leak was noted in sample 4 at approximately 425mmhg.Sample 4 most likely leaked during the second leak test after re-tightening the large bore cap because dried buffer solution was removed during the first leak test and loosening of the cap.A retention sample of the same product code and lot number combination of was visually inspected, and no visual anomalies were noted.The retention sample was also leak tested, and no leaks were noted.The likely root cause for this event is a lack of sealing between the large bore adapter (blue cap) and the shunt sensor body.When the large blue vent cap is tightened, interference between the threads of the cap and the shunt sensor body exist, causing an inadequate seal leading to a leak.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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