Fujitsu Healthy Living Implementation Guide
1.1.28 - release
Publication Build: This will be filled in by the publication tooling
{
"resourceType" : "AdverseEvent",
"id" : "adverse-event-device-death",
"meta" : {
"profile" : [
🔗 "http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-adverseEvent-clinical-research"
]
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"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: AdverseEvent</b><a name=\"adverse-event-device-death\"> </a><a name=\"hcadverse-event-device-death\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource AdverseEvent "adverse-event-device-death" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-fujitsu-adverseEvent-clinical-research.html\">Fujitsu Adverse Event Clinical Research</a></p></div><p><b>Fujitsu Adverse Event Grade</b>: Grade 5 Death related to adverse event <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C48275)</span></p><blockquote><p><b>Fujitsu Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Required Intervention to Prevent Permanent Impairment/damage <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C201939)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: false</p></blockquote><p><b>Fujitsu Resulting Effect</b>: <span>: Condition with Deep puncture wound (disorder) - SNOMED CT code. Note this different than the AdverseEvent.code in this instance.</span></p><blockquote><p><b>Fujitsu Participant</b></p><blockquote><p><b>url</b></p><code>actor</code></blockquote><p><b>value</b>: <a href=\"Practitioner-practitioner-owen-oncologist.html\">Practitioner/practitioner-owen-oncologist</a> " ONCOLOGIST"</p><blockquote><p><b>url</b></p><code>function</code></blockquote><p><b>value</b>: authenticator <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-v3-ParticipationType.html\">ParticipationType</a>#AUTHEN)</span></p></blockquote><blockquote><p><b>Fujitsu Suspect Entity</b></p><blockquote><p><b>url</b></p><code>instance</code></blockquote><p><b>value</b>: <a href=\"MedicationAdministration-medication-administration-kadcyla1.html\">MedicationAdministration/medication-administration-kadcyla1</a></p><blockquote><p><b>url</b></p><code>causality</code></blockquote></blockquote><p><b>Fujitsu Expected In Research Study</b>: false</p><p><b>Fujitsu Note</b>: During infusion of kadcyla an infuser exploded, shrapnel from the explosion caused a fatal puncture wound.</p><blockquote><p><b>modifierExtension[http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-status]</b></p></blockquote><p><b>actuality</b>: actual</p><p><b>category</b>: Device <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-adverse-event-category.html\">AdverseEventCategory</a>#device)</span></p><p><b>event</b>: Patient death due to device explosion <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"https://browser.ihtsdotools.org/\">SNOMED CT</a>#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)")</span></p><p><b>subject</b>: <a href=\"Patient-patient-example-kaitlyn-b1.html\">Patient/patient-example-kaitlyn-b1</a> " HAMMER"</p><p><b>date</b>: 2020-05-20</p><p><b>seriousness</b>: Serious <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-adverse-event-seriousness.html\">AdverseEventSeriousness</a>#serious)</span></p><p><b>outcome</b>: Fatal <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C48275)</span></p><p><b>recorder</b>: <a href=\"Practitioner-practitioner-oncology-nurse-jane.html\">Practitioner/practitioner-oncology-nurse-jane</a> " NURSE"</p><p><b>study</b>: <a href=\"ResearchStudy-clinical-trial-example-compass.html\">ResearchStudy/clinical-trial-example-compass</a></p></div>"
},
"extension" : [
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"url" : "http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-ae-grade",
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"text" : "Grade 5 Death related to adverse event"
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"url" : "criterionCode",
"valueCodeableConcept" : {
"coding" : [
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"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
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"url" : "criterionPresent",
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"url" : "http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-seriousness-criteria"
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{
"url" : "http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-resulting-effect",
"valueReference" : {
"display" : "Condition with Deep puncture wound (disorder) - SNOMED CT code. Note this different than the AdverseEvent.code in this instance."
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{
"extension" : [
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"url" : "actor",
"valueReference" : {
🔗 "reference" : "Practitioner/practitioner-owen-oncologist"
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"valueCodeableConcept" : {
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"url" : "http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-participant"
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{
"extension" : [
{
"url" : "instance",
"valueReference" : {
🔗 "reference" : "MedicationAdministration/medication-administration-kadcyla1"
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"extension" : [
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"url" : "entityRelatedness",
"valueCodeableConcept" : {
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"url" : "causality"
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"url" : "http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-suspect-entity"
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{
"url" : "http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-expected-in-research-study",
"valueBoolean" : false
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{
"url" : "http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-note",
"valueAnnotation" : {
"text" : "During infusion of kadcyla an infuser exploded, shrapnel from the explosion caused a fatal puncture wound."
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"modifierExtension" : [
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"url" : "http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-status",
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"actuality" : "actual",
"category" : [
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"coding" : [
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"code" : "device",
"display" : "Device"
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"event" : {
"coding" : [
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"system" : "http://snomed.info/sct",
"code" : "370903006",
"display" : "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)"
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],
"text" : "Patient death due to device explosion"
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"subject" : {
🔗 "reference" : "Patient/patient-example-kaitlyn-b1"
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"date" : "2020-05-20",
"seriousness" : {
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"text" : "Fatal"
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🔗 "reference" : "Practitioner/practitioner-oncology-nurse-jane"
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🔗 "reference" : "ResearchStudy/clinical-trial-example-compass"
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