The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, leakage was observed at the blue luer cap.Per user facility, the extension tube was suspected to be a cause and replaced however, leakage was observed even at the head.No patient involvement.The product was changed out.The surgery 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 february 8, 2021.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 10, 11, 3331, 213, 4315).Type of investigation #1: 10 - testing of actual/suspected device.Type of investigation #2: 11 - testing of device from same lot/batch retained by manufacturer.Type of investigation #3: 3331 - analysis of production records.Investigation findings: 213 - no device problem found.Investigation conclusions: 4315 - cause not established.The returned sample was visually inspected.The sample was returned without the sparger assembly or the white luer cap.Crystallization of buffer solution was noted in the threads of the blue cap.The returned sample was then leak tested (as received) by connecting with the calibrated manometer, submerged into a water bath, and pressurized up to 1030 mmhg, and no leaks were noted.The large bore adapter blue cap would not loosen by hand and the unit was soaked in di water for several hours to dissolve the crystals.The large bore adapter blue cap was then loosened and re-tightened by hand.The sample was then leak tested a second 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.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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