FDAnews
www.fdanews.com/articles/144243-faulty-software-prompts-alert-for-therapy-device

Faulty Software Prompts Alert for Therapy Device

February 23, 2012
Baxter Healthcare is issuing an alert about three problems with its Aquarius hemofiltration machine using software version 6.01. An update to the software will address the problems: The operating manual incorrectly describes how the filtrate line should be connected for hemoperfusion; if users repeatedly clear fluid balance alarms without resolving the cause of the alarm, the wrong amount of fluid can be removed from the patient; and specific programming settings that can result in excess filtrate being removed from the patient.