MHRA Device Alert: CareFusion Infusion Pumps

The UK’s regulatory overlord, the MHRA has issued a device alert pertaining to CareFusion’s Alaris® GP, GP Guardrails®, GP Plus and GP Plus Guardrails Infusion pumps, product codes 80263UN01, 80263UN01-G, 9002MED01, 9002MED01-G.

Background

In affected pumps it seems that a fault with the front and rear bearings of the pump’s stepper motor may cause it to stall during an infusion. The pump stops, alarms and displays a ‘DRV1’ or ‘DRV2’ error on the screen. The motor stall condition may occur during start-up (immediately after the start key is pressed) or during an infusion, which may result in the early termination of an infusion. Early termination of an infusion could require intervention especially if critical drugs are being administered

Customers are being asked to identify affected pumps, and consider using an alternative pump, particularly if an interruption to an infusion could compromise patient safety. Of note, the company is not due to start shipping replacement motors until September. In the event that an alternative pump is not available, the advice is to follow the manufacturer’s instructions for use. In particular if a ‘DRV1 or DRV2’ error is displayed, immediately remove the pump from use and contact CareFusion.

When available, customers are asked to ensure the stepper motors are replaced.

The full MHRA Alert can be found here.