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 investigation.Conclusions code: conclusion not yet available.
|
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 september 26, 2018.(b)(4).The returned sample was visually inspected, and was noted to contain dried buffer.The sample was returned without the sparger assembly and without the white cap.The returned sample was leak tested (as received) by connecting with the calibrated manometer, submerged into a water bath, and pressurized up to 1030 mmhg.No leaks were noted.This was most likely attributed to the dried buffer within the connection threads to the large blue cap.The shunt sensor was then soaked in a di water.The large bore adapter blue cap was then loosened and re-tightened by hand.It was then leak tested the second time by connecting with the calibrated manometer, submerged into a water bath, pressurized up to 1030 mmhg, and a leak was noted from the large blue luer cap at approximately 390 mmhg.The large blue cap was again loosened and re-tightened with calibrated torque wrench to product specification.It was leak tested the third time, and a leak was noted form the large blue luer cap at approximately 550 mmhg.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 leak tested, pressurized with air up to 1030 mmhg, and no leaks were noted.The complaint was confirmed and the 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.
|