{
  "resourceType" : "AdverseEvent",
  "id" : "adverse-event-device-death",
  "meta" : {
    "profile" : ["http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/AdverseEvent-clinical-research"]
  },
  "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 &quot;adverse-event-device-death&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-AdverseEvent-clinical-research.html\">Adverse Event Clinical Research</a></p></div><p><b>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>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Results In Persistent Or Significant Disability <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>#C11338)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: false</p></blockquote><blockquote><p><b>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Requires Inpatient Hospitalization <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>#C83052)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: false</p></blockquote><blockquote><p><b>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: 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>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: true</p></blockquote><blockquote><p><b>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Is Life Threatening <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>#C84266)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: false</p></blockquote><blockquote><p><b>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Congenital Anomaly or Birth Defect <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>#C83117)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: false</p></blockquote><blockquote><p><b>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Other Medically Important Condition <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>#C82521)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: false</p></blockquote><blockquote><p><b>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>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>Participant</b></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><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> &quot; ONCOLOGIST&quot;</p></blockquote><blockquote><p><b>Suspect Entity</b></p><blockquote><p><b>url</b></p><code>instance</code></blockquote><p><b>value</b>: <a href=\"Device-device-infuser.html\">Device/device-infuser</a></p><blockquote><p><b>url</b></p><code>causality</code></blockquote></blockquote><blockquote><p><b>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>Expected In Research Study</b>: false</p><p><b>Note</b>: During infusion of kadcyla an infuser exploded, shrapnel from the explosion caused a fatal puncture wound.</p><blockquote><p><b>modifierExtension[http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/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 &quot;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)&quot;)</span></p><p><b>subject</b>: <a href=\"Patient-patient-example-kaitlyn-b1.html\">Patient/patient-example-kaitlyn-b1</a> &quot; HAMMER&quot;</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> &quot; NURSE&quot;</p><p><b>study</b>: <a href=\"ResearchStudy-clinical-trial-example-compass.html\">ResearchStudy/clinical-trial-example-compass</a></p></div>"
  },
  "extension" : [{
    "url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/ae-grade",
    "valueCodeableConcept" : {
      "coding" : [{
        "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
        "code" : "C48275"
      }],
      "text" : "Grade 5 Death related to adverse event"
    }
  },
  {
    "extension" : [{
      "url" : "criterionCode",
      "valueCodeableConcept" : {
        "coding" : [{
          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
          "code" : "C11338",
          "display" : "Results In Persistent Or Significant Disability"
        }]
      }
    },
    {
      "url" : "criterionPresent",
      "valueBoolean" : false
    }],
    "url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria"
  },
  {
    "extension" : [{
      "url" : "criterionCode",
      "valueCodeableConcept" : {
        "coding" : [{
          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
          "code" : "C83052",
          "display" : "Requires Inpatient Hospitalization"
        }]
      }
    },
    {
      "url" : "criterionPresent",
      "valueBoolean" : false
    }],
    "url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria"
  },
  {
    "extension" : [{
      "url" : "criterionCode",
      "valueCodeableConcept" : {
        "coding" : [{
          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
          "code" : "C48275",
          "display" : "Death Related to Adverse Event"
        }]
      }
    },
    {
      "url" : "criterionPresent",
      "valueBoolean" : true
    }],
    "url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria"
  },
  {
    "extension" : [{
      "url" : "criterionCode",
      "valueCodeableConcept" : {
        "coding" : [{
          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
          "code" : "C84266",
          "display" : "Is Life Threatening"
        }]
      }
    },
    {
      "url" : "criterionPresent",
      "valueBoolean" : false
    }],
    "url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria"
  },
  {
    "extension" : [{
      "url" : "criterionCode",
      "valueCodeableConcept" : {
        "coding" : [{
          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
          "code" : "C83117",
          "display" : "Congenital Anomaly or Birth Defect"
        }]
      }
    },
    {
      "url" : "criterionPresent",
      "valueBoolean" : false
    }],
    "url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria"
  },
  {
    "extension" : [{
      "url" : "criterionCode",
      "valueCodeableConcept" : {
        "coding" : [{
          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
          "code" : "C82521",
          "display" : "Other Medically Important Condition"
        }]
      }
    },
    {
      "url" : "criterionPresent",
      "valueBoolean" : false
    }],
    "url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria"
  },
  {
    "extension" : [{
      "url" : "criterionCode",
      "valueCodeableConcept" : {
        "coding" : [{
          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
          "code" : "C201939",
          "display" : "Required Intervention to Prevent Permanent Impairment/damage"
        }]
      }
    },
    {
      "url" : "criterionPresent",
      "valueBoolean" : false
    }],
    "url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria"
  },
  {
    "url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resultingEffect",
    "valueReference" : {
      "display" : "Condition with Deep puncture wound (disorder) - SNOMED CT code. Note this different than the AdverseEvent.code in this instance."
    }
  },
  {
    "extension" : [{
      "url" : "function",
      "valueCodeableConcept" : {
        "coding" : [{
          "system" : "http://terminology.hl7.org/CodeSystem/v3-ParticipationType",
          "code" : "AUTHEN"
        }]
      }
    },
    {
      "url" : "actor",
      "valueReference" : {
        "reference" : "Practitioner/practitioner-owen-oncologist"
      }
    }],
    "url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/participant"
  },
  {
    "extension" : [{
      "url" : "instance",
      "valueReference" : {
        "reference" : "Device/device-infuser"
      }
    },
    {
      "extension" : [{
        "url" : "entityRelatedness",
        "valueCodeableConcept" : {
          "coding" : [{
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code" : "C53260",
            "display" : "Related"
          }]
        }
      }],
      "url" : "causality"
    }],
    "url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity"
  },
  {
    "extension" : [{
      "url" : "instance",
      "valueReference" : {
        "reference" : "MedicationAdministration/medication-administration-kadcyla1"
      }
    },
    {
      "extension" : [{
        "url" : "entityRelatedness",
        "valueCodeableConcept" : {
          "coding" : [{
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code" : "C53256",
            "display" : "Not Related"
          }]
        }
      }],
      "url" : "causality"
    }],
    "url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity"
  },
  {
    "url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/expected-in-research-study",
    "valueBoolean" : false
  },
  {
    "url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/note",
    "valueAnnotation" : {
      "text" : "During infusion of kadcyla an infuser exploded, shrapnel from the explosion caused a fatal puncture wound."
    }
  }],
  "modifierExtension" : [{
    "url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/status",
    "valueCode" : "completed"
  }],
  "actuality" : "actual",
  "category" : [{
    "coding" : [{
      "system" : "http://terminology.hl7.org/CodeSystem/adverse-event-category",
      "code" : "device",
      "display" : "Device"
    }]
  }],
  "event" : {
    "coding" : [{
      "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)"
    }],
    "text" : "Patient death due to device explosion"
  },
  "subject" : {
    "reference" : "Patient/patient-example-kaitlyn-b1"
  },
  "date" : "2020-05-20",
  "seriousness" : {
    "coding" : [{
      "system" : "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness",
      "code" : "serious",
      "display" : "Serious"
    }]
  },
  "outcome" : {
    "coding" : [{
      "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
      "code" : "C48275"
    }],
    "text" : "Fatal"
  },
  "recorder" : {
    "reference" : "Practitioner/practitioner-oncology-nurse-jane"
  },
  "study" : [{
    "reference" : "ResearchStudy/clinical-trial-example-compass"
  }]
}