The prismax device was evaluated on site by a qualified baxter technician.A calibration and system self-test (sst) were performed with no further issues reported.Scheduled preventive maintenance (pm) was also executed.The return pressure sensor was replaced.The reported problem was verified.The event history log review was performed and it confirmed the occurrence of a technical alarm b1116: ¿return pressure self - test fail¿, as intended after a failed pod reposition and requiring the return pressure sensor to be changed.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The reported condition was verified.The cause was a faulty pressure sensor.Should additional relevant information become available, a supplemental report will be submitted.
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It was reported that a pediatric patient experienced arterial hypotension and hypoxia during a continuous renal replacement therapy treatment, using a prismax machine and a prismaflex hf20 set.It was reported that the prismax machine generated an alarm: b1116: ¿return pressure self - test fail¿ and the screen became black.This error code was preceded 15 minutes before by alarm t0525 (return disconnection).The treatment was ended with only part of the extracorporeal blood being returned to the patient using the hand crank.During the change of circuit, the pediatric patient was in arterial hypotension and hypoxic which required refilling by supply of platelets and plasma.At the time of this report, the patient has recovered from the event.No additional information is available.
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