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1RareDifficult to believe it could happen again
2UnlikelyNot expected to happen again
3PossibleMay occur occasionally
4LikelyExpected to happen again but not persistent
5ProbablyExpected to happen again on many occasions

 

 

STEP 2: EFFECT: ASSESSING IMPACT/CONSEQUENCES OF SARE SHOULD IT OCCUR

 

 Impact levelEffect on donor/patient; potential in case of SAE, actual in case of SAROn systemOn cell supply
0InsignificantNilNo effectInsignificant
1MinorNon-seriousMinor changeSome applications postponed
2ModerateSeriousDamage for a short periodMany cancellations or postponements
3MajorLife threateningMajor damage to system-significant delay to repairSignificant cancellations-importation required
4CatastrophicDeathSystem destroyed - need to rebuildAll allogeneic applications cancelled