It was reported that during a continuous renal replacement therapy treatment, using a prismax control unit , the help screen froze whilst attempting to enter the patient hematocrit values.An alarm related to high pressures was generated by the machine, however, it was not possible to enter the treatment screen due to the frozen screen.The treatment was ended with a blood loss of 150 ml.The extracorporeal blood was not returned to the patient.The patient was transfused with one unit of packed cells.The patient outcome was not reported.No additional information is available.
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H10: 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; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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