The U.K.’s Medicines & Healthcare Products Regulatory Agency issued an 2nd warning for CareFusion‘s Alaris drug pump after the company discovered that the Alaris pumps with broken springs in the plunger assembly could accidentally release a single dose of medication.
The UK watchdog 1st warned customers in December last year that the pump could release a dose of medication if it was used with non-recommended syringes.
“Since we published MDA/2016/023, the manufacturer has identified the potential for a broken spring in the plunger assembly to cause an unintended movement of the syringe plunger, which may result in a bolus of up to 0.5ml. This problem may be significant in the treatment of paediatric patients,” the group wrote. “This issue may affect all syringes (recommended and non-recommended) when used in the specified Alaris syringe pumps.”
Users should contact CareFusion to learn how to check the plunger holder’s springs and inform the company if they identify a broken spring, the regulatory group cautioned.
Users have until March 13, 2017 to begin taking action and must be in compliance with the agency’s recommendations by April 26.
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.