It was reported that after six hours of continuous renal replacement therapy using a prismaflex m100 with citrate anticoagulant, the set clotted."lipid or fibrinoid kind of deposition" was observed on the filter top and other parts of the deaeration chamber and return line.Treatment was restarted with a new m100 set using heparin as anticoagulant.Within an hour, filter pressure reached above 200 and tmp above 100 and early clotting of the filter was observed.No additional information is available.
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Additional information: h3, h6 and h10.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.The visual inspection of the provided picture could not identify any specific defect on the impacted set.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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