FMEA Table



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 |Makes device dangerous on |Eye is damaged internally by |10 |Tip comes close to walls or other |Clinicians are trained to operate |

| |into the eye |insertion |the injector | |internal sections of the eye |device properly |

|BSS Irrigator |Irrigation despite high |BSS is pushed into the eye |Eye is damaged by internal |14 |Eye grows and bulges due to |Pressure calculator in the |

| |pressure or not enough |although eye is above nominal|pressure | |irrigation, or eye shrinks in shape |irrigation device, emergency cut |

| |irrigation |pressure, or rate of BSS is |or lack of pressure | |due to lack of pressure |off |

| | |not high enough | | | | |

|Moving part of the injector |Moving part touches |Tissue undergoes friction |Friction damages the |17 |Syringe harder to push, tissue is |Tracks in the device to prevent |

| |outside wall | |implantation tissue | |damaged |friction |

|Vacuum ports |Vacuum ports fail to keep |Donor Tissue damaged during |Damage to donor tissue |10 |Clinician notices that tissue falls |Training of clinicians, vacuum |

| |tissue attached |surgery because it | | |off through transparent tip |ports optimally sized |

| | |disconnects from injector | | | | |

|Material of Device |Material is not |Material makes device unsafe |Material causes damage to eye|17 |Material causes allergic or |Materials chosen that are |

| |biocompatible |to patient | | |non-biocompatible reaction |biocompatible |

Probability vs. Severity Matrix

|Probability of |Severity I |Severity II |Severity III |Severity IV |

|Occurrence |Catastrophic |Significant |Marginal |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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