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).
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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 september 11, 2018.(b)(4).All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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This follow-up report is submitted to fda in accord with applicable regulations.(b)(4).The returned sample was visually inspected.No other visual anomalies were noted.The unit was pressurized with air (as received) up to 1030 mmhg, submerged in a water bath, and observed for any leaks.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 in a water bath, and observed for any leaks.A leak was noted from the large blue luer cap while attempting to hold the 1030 mmhg pressure after approximately 10 seconds.The leak was most likely noted after loosening and retightening the cap because dried buffer solution deposits within the threads of the large bore cap and the shunt body were removed during the submersion test and manipulation of the cap for retesting.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 up to 1030 mmhg, submerged in a water bath, and observed for any leaks.No leaks were noted on the retention sample.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.
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