Alaris & BD Alaris Point-Of-Care Unit (PCU)

Issue

Becton Dickinson (BD) is issuing this voluntary product communication because its labeling does not indicate which Transport Layer Security (TLS) versions must be enabled on the hospital network to ensure secure wi-fi communication with the Alaris and BD Alaris™ Point-of-Care Unit (PCU) when using enterprise-level wi-fi security. Without clear labeling, hospitals may unknowingly disable TLS 1.0, resulting in network connectivity failure and memory leaks which could lead to potential system error. Alaris™ and BD Alaris™ PCUs (v12.1.3 and prior) are not compatible with TLS security frameworks beyond TLS 1.0. If TLS 1.0 is disabled on the customer network, the PCUs will fail to connect to the wireless network. For customers utilizing bi-directional workflow, this leads to interoperability failures which require users to manually program devices. If TLS 1.0 is disabled on the customer network during use, PCUs (V12.1.3 and prior) may encounter a memory leak when the authentication fails, which consumes over time, all available memory and leads to a system error. This may happen during active infusions. Future versions of BD Alaris™ PCUs that are not yet available in Canada will be compatible with TLS 1.0, 1.1, and 1.2.