FMEAFMEAComponentComponent Failure Failure

ModeModeEffect on Effect on SystemSystem

Possible Possible HazardsHazards

Risk IndexRisk Index User User Detection Detection MeansMeans

Applicable Applicable Control(s)Control(s)

NeedleNeedle Breaking offBreaking off Injection Injection failurefailure

Emergency Emergency surgery to surgery to remove remove needle from needle from patient’s patient’s abdomenabdomen

1010 Pain, missing Pain, missing needle tipneedle tip

User User instructions, instructions, stress tests, stress tests, revised revised procedure for procedure for injectioninjection

NeedleNeedle BendingBending Injection Injection failure, failure, possible possible incorrect incorrect dosagedosage

Blood sugar Blood sugar fluctuations fluctuations from incorrect from incorrect insulin insulin dosage, dosage, possible possible complicationscomplications

88 Visual Visual inspection of inspection of needleneedle

User User instructions, instructions, stress tests, stress tests, revised revised procedure for procedure for injectioninjection

PlungerPlunger JammingJamming Injection Injection failure, failure, possible possible incorrect incorrect dosagedosage

Insulin under Insulin under dose, coma, dose, coma, deathdeath

88 Visual Visual inspection of inspection of plungerplunger

New design New design (possibly (possibly ejection ejection sensor)sensor)

Risk IndexRisk IndexProbability of OccurrenceProbability of Occurrence Severity I: Severity I:

CatastrophicCatastrophic

(Death, serious injury)(Death, serious injury)

Severity II: Severity II:

SignificantSignificant

(Reversible serious (Reversible serious injury)injury)

Severity III:Severity III:

MarginalMarginal

(Inconvenience)(Inconvenience)

Severity IV:Severity IV:

NegligibleNegligible

FrequentFrequent 11 33 77 1313

ProbableProbable 22 55 99 1616

OccasionalOccasional 44 66 1111 1818

RemoteRemote 88 1010 1414 1919

ImprobableImprobable 1212 1515 1717 2020

Risk Index TableRisk Index Table

Hazard Risk IndexHazard Risk Index Acceptance CriteriaAcceptance Criteria

1-71-7 Intolerable: Must never arise or result in an Intolerable: Must never arise or result in an accidentaccident

8-158-15 As low as reasonably practical (ALARP): Must As low as reasonably practical (ALARP): Must minimize possibility of hazard given cost and minimize possibility of hazard given cost and schedule constraintsschedule constraints

17-2017-20 Acceptable: Consequences of hazard are Acceptable: Consequences of hazard are acceptable and no extra cost should be acceptable and no extra cost should be incurred to reduce hazard probabilityincurred to reduce hazard probability