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 january 8, 2019. upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added exp date).D10 (device availability - added date returned to manufacturer).G4 (date received by manufacturer).G7 (indication that this is a follow-up report).H2 (follow-up due to additional information and device evaluation).H3 (device evaluated by manufacturer).H4 (device manufacture date).H6 (identification of evaluation codes 10, 11, 3331, 4210, 4307).Method code #1: 10 - testing of actual/suspected device.Method code #2: 11 - testing of device from same lot/batch retained by manufacturer.Method code #3: 3331 - analysis of production records.Results code: 4210 - leakage/seal.Conclusions code: 4307 - cause traced to component failure.The returned sample was visually inspected and was noted to contain dried buffer.It was returned without the sparger assembly and without the cap.It was then leak tested (as received) by connecting with the calibrated manoneter, submerged into a water bath, pressurized up to 1030 mmhg, and a leak was noted from the large blue cap at approximately 125 mmhg.The large bore adapter blue cap was then loosened and re-tightened by hand.It was again leak tested, pressurized up to 1030 mmhg, and a leak was noted from the large blue luer cap at approximately 525 mmhg.The large blue cap was again loosened and retightened with a calibrated torque wrench to product specifications.It was leak tested for the third time, and a leak was noted from the large blue luer cap while holding at 1030 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.It was also leak tested 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.
|