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: 2645 - no patient involvement.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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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 october 6, 2023.Type of investigation #1: 10 - testing of actual/suspected device type of investigation #2: 3331 - analysis of production records investigation findings: 213 - no device problem found investigation conclusions: 67 - no problem detected the returned sample was visually inspected upon receipt, during which it was noted that the sparger assembly and white luer cap were not present.A white luer cap was added to the sample.A white luer cap was added to the sample, and the returned sample was then leak tested, as received.It was connected with a calibrated manometer, submerged into a water bath, and pressurized up to 1030 mmhg and a leak was noted immediately.The large bore adapter blue cap was then loosened and re-tightened by hand.The sample was then leak tested a second time by connecting with the calibrated manometer, submerged into a water bath, and pressurized up to 1030 mmhg, and no leaks were 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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