1. Risk Scoring Parameters Severity (choose most severe) Risk Ranking Likelihood ProductProjectInjury 3 Highly Likely > 50% Complete product failure, does not function Complete project failure Severe injury, potential death 2 Somewhat Likely 20% - 50% Meets some customer needs and specifications, product performs with less functionality than desired Moderate impact to budget schedule Treatment required 1 Rare 0 - 20% Performance of product is not impacted No impact to project budget or schedule Minor or no injury Score level to Change Color: LikelihoodSeverity RPN Red337 Yellow224 Green111

2. Summary Likelihood (1-3) Severity (1-3) RPN Total Number of 3's2362 Risk ItemDescription/Comment Likelihood Severity Level Risk Priority Number Cost SensorsDesired sensor accuracy not within budget224 DAQDedicated DAQ system not within budget339 Temperature Control Method for keeping constant temperature (98 deg F) not within budget224 Resistance Automation Controlling the flow restriction (resistance) using DAQ not within budget326 Physiological Simulation ComplianceSpecified compliance values not achieved224 ResistanceSpecified resistance values not achieved224 TemperatureHuman body temperature is not maintained224 Viscosity Viscosity variation does not simulate human blood properties122

3. Risk ItemDescription/Comment Likelihood Severity Level Risk Priority Number Materials Biocompatibility Not all necessary components are biocompatible224 DurabilityValves, sensors, tubing degrade over time122 Measurement Inaccurate measurements Pressure and flow measurements are inaccurate122 DAQ Error Instrumentation and DAQ not communicating properly, DAQ does not collect or output data properly236 Design Robustness System is not robust - variations in functionality and system output224 Leak System or components leak causing error in measurement and/or contamination224 Resistance Automation Flow restriction is not automated or does not function properly133