Plum 360 Infusion System With Mednet

Due to a manufacturing defect of a supplier provided component, there is a potential that the audible signal for an alarm may not sound under certain conditions. Alarms on Plum 360 consist of three elements: a visual alarm indication, an audible signal, and a message that appears on the display. Plum 360 pumps test the primary alarm audible signal during the power-on sequence. If the pump detects a failure of the audible signal during power-on, the pump display will remain off and the line b drip indicator will flash, indicating the pump has failed power-on. If the audible signal fails after passing the power-on test and during the use of the pump, a situation may occur where the pump has stopped infusion and an alarm is triggered without an audible signal. The pump will remain in this state until a clinician addresses the alarm. The visual alarm indication and the message will still appear on the display.

 

Recall start date: July 5, 2023