Generated Narrative: AdverseEvent

Fujitsu Adverse Event Grade: Grade 5 Death related to adverse event (NCI Thesaurus#C48275)

Fujitsu Criteria reviewed in determining serious adverse event

url

criterionCode

value: Required Intervention to Prevent Permanent Impairment/damage (NCI Thesaurus#C201939)

url

criterionPresent

value: false

Fujitsu Resulting Effect: : Condition with Deep puncture wound (disorder) - SNOMED CT code. Note this different than the AdverseEvent.code in this instance.

Fujitsu Participant

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actor

value: Practitioner/practitioner-owen-oncologist " ONCOLOGIST"

url

function

value: authenticator (ParticipationType#AUTHEN)

Fujitsu Suspect Entity

url

instance

value: MedicationAdministration/medication-administration-kadcyla1

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causality

Fujitsu Expected In Research Study: false

Fujitsu Note: During infusion of kadcyla an infuser exploded, shrapnel from the explosion caused a fatal puncture wound.

modifierExtension[http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-status]

actuality: actual

category: Device (AdverseEventCategory#device)

event: Patient death due to device explosion (SNOMED CT#370903006 "Patient death or serious disability associated with the use or function of a device in patient care, in which the device is used or functions other than as intended (event)")

subject: Patient/patient-example-kaitlyn-b1 " HAMMER"

date: 2020-05-20

seriousness: Serious (AdverseEventSeriousness#serious)

outcome: Fatal (NCI Thesaurus#C48275)

recorder: Practitioner/practitioner-oncology-nurse-jane " NURSE"

study: ResearchStudy/clinical-trial-example-compass