Quantitative and qualitative safety analysis of a hemodialysis machine with S#

Abstract

This paper reports on our experiences of applying S# ("safety sharp") to model and analyze the case study "hemodialysis machine." The S# safety analysis approach focuses on the question, what happens if we place a controller with correct software into an unreliable environment. To answer that question, the S# toolchain natively supports the Deductive Cause Consequence Analysis, a fully automatic model checking-based safety analysis technique that determines all sets of component faults with the potential of causing a system hazard. Furthermore, S# can give an approximate estimate of the hazard's probability. To demonstrate our approach, we created a model with a simplified controller of the hemodialysis machine and relevant parts of its environment and performed a safety analysis using Deductive Cause Consequence Analysis. KEYWORDSdeductive cause consequence analysis, design tools and techniques, embedded domain specific language, executable models, formal methods, hemodialysis, model checking, quantitative analysis, safety analysis, simulation

A comparative risk assessment of dialysis care processes in the home and hospital care contexts

“…Application of Fault Tree Analysis for clinical risk factors affecting patient safety is discussed in several studies, including assessing safety of anesthesia (Liu and Yuan 2015;Culwick et al 2016), maintenance-related hazards of medical devices (Mahfoud et al 2016;García et al 2019;Labagnara et al 2013) or assessing risk profiles of programs for stereotactic radiosurgery (Teixeira et al 2016). More recent applications of Fault Tree Analysis for dialysis treatment is discussed for management of medical waste (Makajic-Nikolic et al 2016), and assessing hazards of hemodialysis devices, (Leupolz et al 2018).…”

Smart System Modeling and Simulation design of Hemodialysis Machine by SysML with SystemC-AMS

“…Furthermore, S# can supply an approximate estimate of the risk probability. A version is created with a simplified controller of the hemodialysis device and applicable components of its surroundings to carry out a protection evaluation of the usage of Deductive Cause Consequence Analysis [17,18]. The research work of gives a proper specification approach for a hemodialysis device with the use of Event-B [19,20].…”

Smart System Modeling and Simulation design of Hemodialysis Machine by SysML with SystemC-AMS

“…Furthermore, S# can supply an approximate estimate of the risk probability. A version is created with a simpli ed controller of the hemodialysis device and applicable components of its surroundings to carry out a protection evaluation of the usage of Deductive Cause Consequence Analysis [17] [18]. The research work of [19] gives a proper speci cation approach for a hemodialysis device with the use of Event-B [20].…”