The U.K.’s Medicines & Healthcare Products Regulatory Agency issued a warning today for Carefusion‘s Alaris syringe drug pumps. The UK watchdog said that Alaris pumps with broken springs in the plunger assembly could accidentally release a single dose of medication if the pump also uses non-recommended syringes.
“This problem comes about through a combination of using non-recommended syringes with a pump that has a broken spring in the syringe driver plunger housing,” the regulatory agency wrote. “To date CareFusion has not identified an increased risk of this problem when recommended syringes are used.”
Users should contact CareFusion to learn how to check the plunger holder’s springs if the pump is displaying ‘check syringe’ alarms. The regulatory group also cautioned that the pump should only be used with recommended syringes and that the syringe pumps should be regularly maintained.
Users have until January 10, 2017 to begin taking action and must be in compliance with the agency’s recommendations by February 7.
This is the latest in a series of warnings issued to CareFusion regarding its Alaris pumps over the past few years. In August 2015, the FDA issued 2 Class 1 recall notices related to the pump over alarm issues and the pump’s replacement frame membrane.
The company also initiated 2 class 1 recalls between 2013 and 2014 over software issues with the Alaris pump.