The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, a leakage was observed at the part connected to the circuit.Per user facility the shunt sensor was attached to the bpm probe in the artery side of the bpm and a leakage was observed at the connected portion.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 august 14, 2020.Upon further investigation of the reported event, the following information is new and/or changed: 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) h3 (device evaluation anticipated by manufacturer - a second follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references conclusions code 11.) 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.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 10, 11, 3331, 213, 67).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: 213 - no device problem found.Conclusions code: 67 - no problem detected.The returned sample was visually inspected.The sample was returned without the sparger assembly or the white luer cap.The returned sample was then leak tested by connecting with the calibrated manometer, submerged into a water bath, and pressurized where the unit leaked at 100mmhg.It was then attached to a bpm head and leak tested a second time with no issue.The large bore adapter blue cap was then loosened and re-tightened by hand.The sample was then leak tested a third 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.The retention sample was then pressurized with air up to 1030 mmhg, submerged in a water bath, and observed for any leaks.It was leak tested a second time attached to a bpm head.No leaks were noted on the retention sample.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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