Failure Mode Effects Analysis- Revision 2 April 11, 2007

Kristen Berger, Paul Bieniek, Dave Brooks, Marie Gill Advisor: Ahmed Al-Ghoul

Failure Mode Effects Analysis - Corneal Membrane Transplant Injector

Function or Component / Failure Mode / Effect on System / Possible Hazards / Risk Index / User Detection Means / Applicable Controls
Tip of injector / Tip is inserted too deep into the eye / Makes device dangerous on insertion / Eye is damaged internally by the injector / 10 / Tip comes close to walls or other internal sections of the eye / Clinicians are trained to operate device properly
BSS Irrigator / Irrigation despite high pressure or not enough irrigation / BSS is pushed into the eye although eye is above nominal pressure, or rate of BSS is not high enough / Eye is damaged by internal pressure
or lack of pressure / 14 / Eye grows and bulges due to irrigation, or eye shrinks in shape due to lack of pressure / Pressure calculator in the irrigation device, emergency cut off
Moving part of the injector / Moving part touches outside wall / Tissue undergoes friction / Friction damages the implantation tissue / 17 / Syringe harder to push, tissue is damaged / Tracks in the device to prevent friction
Vacuum ports / Vacuum ports fail to keep tissue attached / Donor Tissue damaged during surgery because it disconnects from injector / Damage to donor tissue / 10 / Clinician notices that tissue falls off through transparent tip / Training of clinicians, vacuum ports optimally sized
Material of Device / Material is not biocompatible / Material makes device unsafe to patient / Material causes damage to eye / 17 / Material causes allergic or non-biocompatible reaction / Materials chosen that are biocompatible


Probability vs. Severity Matrix

Probability of Occurrence / Severity I
Catastrophic / Severity II
Significant / Severity III
Marginal / Severity IV
Negligible
Frequent / 1 / 3 / 7 / 13
Probable / 2 / 5 / 9 / 16
Occasional / 4 / 6 / 11 / 18
Remote / 8 / 10 / 14 / 19
Improbable / 12 / 15 / 17 / 20


Risk Acceptance Criteria Matrix

Hazard Risk Index / Acceptance Criteria
1 to 5 / Unacceptable
6 to 9 / Undesirable; written and reviewed decision required to proceed
10 to 16 / Acceptable upon completion of quality assurance review
17 to20 / Acceptable without review

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