ICU Medical designed its Plum 360, Plum A+ and Plum A+3 systems for large-volume fluid infusion. The system delivers blood or blood products, drugs and other fluid mixtures through subcutaneous, intramuscular, intravenous, and intrathecal administration.
The company’s recall involves updated instructions, not removing devices from use or sale. ICU Medical identified a manufacturing defect in the batteries, which can lead to a substantial diminishing of battery life. This updated notice expands affected products from a previous March 2023 recall to include all replacement batteries manufactured by CSB.
The FDA has identified this recall as the most serious type. This device may cause serious injury or death if people continue to use it without following the updated instructions.
Batteries and replacement batteries are used when the pump is not plugged into AC power. This may occur during patient transport, for instance. Using affected products can cause serious injury or death due to interrupiton, under-infusion or delays in delivery. ICU Medical reports one injury related to the issue and zero deaths.
The company told clinical users to keep the pump plugged into AC power whenever possible and ensure full battery charge when disconnecting. Users should closely monitor the battery status and have a backup pump available when infusing critical medications.
Biomedical engineers should replace batteries when the pump triggers a replace battery alarm, the company said. They should not use replacement batteries with corroded battery terminals.
