Terumo has not received the device for evaluation; therefore, 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 (b)(4).Results code: results pending completion of evaluation.Conclusions code: conclusion not yet available-evaluation in progress.
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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 dec 2, 2018 (b)(4).The returned sample was visually inspected, no anomalies noted.It was leaked tested by connecting with the calibrated manometer, submerged into a water bath, and pressurized up to 1030 mmhg, and no leaks were noted.The large blue cap was then loosened and retightened with a calibrated torque wrench to production specification.The unit was then pressurized with air, 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.The retention sample was then pressurized with air, submerged in a water bath, and observed for any leaks.No leaks were noted.It is possible that the buffer solution was not completely wiped off the product after buffer fill during manufacturing.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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