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Medical Device Failure Modes and Effects Analysis (FMEA)

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









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