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Infutronix infusion pump recall associated with 6 injuries, 1 death

Healthcare professionals rely on Infutronix's Nimbus infusion pump systems, also marketed as Halo, for administering medications and fluids. These devices deliver liquids subcutaneously, intranerveously, or intravenously, and patients sometimes self-administer pain medications with them.

The recall impacts over 52,000 devices distributed between 2015 and 2024. Users reported issues such as battery malfunctions, blockages, and drug leakage.

In a FDA recall notice, potential harms were outlined. Leaky pumps could cause infections due to microbial contamination, lacking a sterile barrier. Blockages might result in patients receiving insufficient medication or fluids, leading to complications like hypertension, dehydration, and electrolyte imbalances. These faults could lead to seizures, shock, organ failure, or death.

The severity of risks was highlighted when the FDA added the recall to its database in March.

Infutronix halted Nimbus pump shipments and will continue providing administration sets until June 20. Afterward, both pumps and administration sets will be discontinued, possibly requiring FDA premarket notification and clearance due to potential redesign needs.