|
Infusion Pump Software Correction: Becton, Dickinson and Company (BD) Issues Correction for BD Alaris Systems Manager and Care Coordination Engine Infusion Adapter Software Due to Risk for Outdated Automated Programming Requests to Load
Becton, Dickinson and Company is correcting software for the BD Alaris Systems Manager and BD Care Coordination Engine (CCE) Infusion Adapter after receiving reports that customers running with Systems Manager software who are also connected to the system’s CCE Infusion Adapter may experience delayed system response and backlogging of automated programming requests (APRs). After the delay, outdated APRs may upload to the Alaris computer, presenting different rate, dose, or volume parameters than the current infusion. If the outdated rate/dose change is accepted by the user, a patient could receive inaccurate therapy including over- or under-infusion.
The FDA has identified this as a Class I recall, the most serious type of recall. This recall involves correcting software for devices and does not involve removing them from where they are used or sold. This device may cause serious injury or death if you continue to use it without correction.
Questions?
Customers in the U.S. with questions about this recall should contact BD’s Recall Support Center: 888-562-6018 or SupportCenter@bd.com.
|
