System Proposal for Supervision of Critical Adverse Processes in Patients with Implanted Ventricular Assist Devices

Ventricular assist devices (VADs) are designed to provide sufficient blood flow to patients with severe heart failure. Once implanted, the patient becomes dependent on the VAD, making it essential to prevent situations that could harm the patient while receiving circulatory support. VADs are classified as critical systems (CS), and adverse events (AEs) can lead to serious consequences, including hospitalization or even death. At present, patient care is provided through in-person consultations, with incidents reported via medical device reports (MDRs) to the Food and Drug Administration (FDA). However, there is no real-time monitoring of AEs or oversight of these events. In response to this gap, a system for supervising critical adverse processes in patients with implanted VADs (SCVAD) is proposed, based on horizontally and vertically integrated architecture. This system aims to address the complexity of AEs by considering multiple domains of operation: the device, the patient, and the medical team, as well as the interactions between these entities. In this context, the formalism of Petri nets (PN) is used to develop models that represent adverse processes based on the actions recommended by the medical team. These models allow for the mapping of events with the potential to cause harm to the patient. Therefore, the medical team will be able to monitor adverse processes, as the models in interpreted PN can be isomorphically transcribed into computable algorithms that can be processed on compatible devices, enabling the tracking of complications caused by adverse processes.