The US Food and Drug Administration has announced that ICU Medical has recalled the replacement batteries for the Plum 360, Plum A+ and Plum A+3 infusion systems.
The FDA has labelled the action as a Class I recall, which is the regulator’s most serious type of recall, indicating serious injuries or death may occur if the affected devices are used.
The recall was issued due to a manufacturing defect that significantly reduced the life of the batteries, making them run out of power more quickly.
The reduced battery life could potentially affect the delivery of infusions.
The Plum 360, Plum A+ and Plum A+3 are large-volume infusion pumps designed to deliver drugs, blood and other fluid mixtures to patients. They can deliver exact dosages at specific rates of fluids.
The devices can be used plugged into an AC power outlet. The batteries or replacement batteries come into use when the patient is being transported or when the pump is not connected to AC power.
If the pump operates on battery power and no AC power backup is accessible, the system may cease to operate during an ongoing infusion and shut down earlier than anticipated.
This problem could potentially result in significant harm or loss of life for patients due to interruptions, under-infusion or delays in delivering vital medications and fluids.
ICU Medical has been notified of 54 complaints related to Plum 360 and 465 complaints linked to Plum A+/A+3.
No injuries or deaths have been reported by the company.
The company has recalled 1,904 batteries in the US and is committed to replacing all batteries affected by this issue. Customers will be contacted by the company when the batteries are available for battery replacement.
In an urgent medical device correction letter issued to customers in March this year, the company made a slew of recommendations, including keeping the pump plugged into an AC power whenever possible.
The company also suggested that healthcare providers make sure the battery is fully charged when the need arises to unplug the device from the power outlet.