Terumo has received the device for evaluation; however, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.For this reason, terumo references evaluation conclusion code 11.H6: component code: 510 - sensor.Health effect - impact code: 2199 - no health consequences or impact.Health effect - clinical code: 4582 - no clinical signs, symptoms or conditions.Medical device problem code: 1354 - leak/splash.Investigation findings: 3233 - results pending completion of investigation.Investigation conclusions: 11 - conclusion not yet available.
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The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, they noticed leakage during priming.As per the user facility, after the shunt sensor was connected to the tube, priming solution leaked from the connecting part.No health consequences or impact to patient.Product was changed out.Procedure 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 november 17, 2023.The returned sample was visually inspected upon receipt and noted that the sparger assembly and white luer cap were not present.A white luer cap was added to the sample, and was leak tested as received.The sample was connected with a calibrated manometer, submerged into a water bath, and pressurized up to 1030 mmhg, and leak was noted immediately.The large bore adapter blue cap was then loosened and re-tightened by hand, and was then leak tested the same way with no leaks 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, 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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