Hemodialysis equipment malfunction / level detector self regulated adjustment / suspected sensor malfunction/ manufacture outset medical / device model tablo.Machine is designed to automatically adjust the venous level by either infusing air or pulling air from the chamber to adjust the level of this chamber.According to the manufacture they believe a sensor looking at this level is defective causing the pump to infuse air dropping this level to a lower level potentially causing excessive air into the system which would lead to patient loss of blood and delaying therapy as machine would have to be set up again and therapy restarted.Hemodialysis therapy outpatient dialysis clinic.Fda safety report id # (b)(4).
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