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.H3: 81 - evaluation is in progress, but not yet concluded.
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The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime a leakage was observed.As per the subsidiary, during priming, leaks were observed at both ports of the shunt sensor.The shunt sensor was not use and a backup shunt sensor was used without problems.No patient involvement, 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 february 09, 2024.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 10, 11, 3331, 4210, 19).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.It was then leak tested, as received by connecting 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.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.It was then leak tested the way, and no leaks were noted on the retention sample.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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