Failure Modes and Effects Analysis (FMEA)

FMEA is a tool commonly used for analyzing a system fro a “bottom up” point of view. The technique assumes a particular failure occurs, and then determines the effect on patient/operator (if any). Several variants exist, but typical elements are:

• Component description
• Component function
• Failure mode
• Failure Causes
• Failure effects
• Failure detection method (sometimes “detectability”)
• Severity of failure
• Probability of failure
• Corrective action
• Risk level after corrective action

 

FMEA Example:

Item ID	Function	Potential Failure Mode	Potential Effects	Potential Causus of failure	Current Controls	Prob	Sev	Det	Mitigation Reqd?	Suggested Mitigation
Blood Pump	Blood pump and rotor assembly	Flow too high	Too much blood flow, alarms	controller failure	pressure alarm, speed alarm	2	4	1	No	N/A
Blood Pump		Flow too low	Too little blood, alarms	controller failure, rotor failure	pressure alarm	2	4	1	No	N/A
Blood Pump		External leak (positive pressure)	blood loss	tubing set leak	mfg. controls on tubing set	1	5	2	Yes	Warning in manual
Blood Pump		External leak (negative pressure)	air leak into system	tubing set leak	air in blood alarm	2	4	1	No	N/A