BD is recalling hundreds of thousands of its Alaris infusion pumps and vital sign monitors due to multiple system faults, including software- and user-related issues.
According to the FDA, the errors can lead to delays or interruptions in drug infusions or under- or over-dosing of medication at unexpected rates. The agency categorized the recall as Class I, its most serious, following 55 reported injuries and one death.
The recall affects about 774,000 devices in the U.S., distributed from as early as July 2004. This includes system PCs, pump modules and patient-controlled devices for managing pain.
BD and its CareFusion subsidiary alerted users of potential device errors Feb. 4 and have been developing corrective software updates. The company said it would schedule updates with healthcare providers once they are available.
The devices’ main software issues include system errors, low battery alarm failures and alarms sounding at an incorrect lower priority level as well as user-related errors related to the programming of custom medication concentration settings.