It was reported that at an unknown time during continuous renal replacement therapy with a prismaflex control unit and a prismaflex oxiris set , reddish effluent was observed.No blood leak detection alarm was generated, and no effluent sampling was reported for confirmation of red blood cells.It was further reported the patient experienced hemolysis and cardiac arrest.It was reported the patient received continuous cardiac compression rescue.At the time of this report the patient outcome was not reported.No additional information is available.
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Additional information: d4, h3, h6 and h10.H10: the actual sample was not available; however, photos of the sample were provided for evaluation.Visual inspection observed a red coloration in the effluent fluid.The reported condition was verified.The cause could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.A device history review revealed no issues that could have caused or contributed to the reported issue.Should additional relevant information become available, a supplemental report will be submitted.
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