It was reported that during use, one unit of prismaflex st100 set c had an external blood leak due to a rupture in the return end of the tube.There was patient involvement however, no patient injury or medical intervention was reported.No additional information is available.
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Prismaflex st100 set c has been temporarily approved for use in the us under emergency use authorization eua (b)(4) to deliver crrt to treat patients in an acute care environment during the covid-19 pandemic.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; however, based on the information provided, ¿due to the rupture of the return end of the tube¿ meaning broken male luer lock of the return line.This component is provided to baxter meyzieu plant already assembled by our supplier.Should additional relevant information become available, a supplemental report will be submitted.
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