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FHIR IG analytics

Packagehl7.fhir.uv.ae-research-ig
Resource TypeAdverseEvent
IdAdverseEvent-adverse-event-device-death.json
FHIR VersionR5

Resources that use this resource

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Resources that this resource uses

No resources found

Narrative

Note: links and images are rebased to the (stated) source

Generated Narrative: AdverseEvent

Resource AdverseEvent "adverse-event-device-death"

Profile: Adverse Event Clinical Research

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

Criteria reviewed in determining serious adverse event

url

criterionCode

value: Results In Persistent Or Significant Disability (NCI Thesaurus#C11338)

url

criterionPresent

value: false

Criteria reviewed in determining serious adverse event

url

criterionCode

value: Requires Inpatient Hospitalization (NCI Thesaurus#C83052)

url

criterionPresent

value: false

Criteria reviewed in determining serious adverse event

url

criterionCode

value: Death Related to Adverse Event (NCI Thesaurus#C48275)

url

criterionPresent

value: true

Criteria reviewed in determining serious adverse event

url

criterionCode

value: Is Life Threatening (NCI Thesaurus#C84266)

url

criterionPresent

value: false

Criteria reviewed in determining serious adverse event

url

criterionCode

value: Congenital Anomaly or Birth Defect (NCI Thesaurus#C83117)

url

criterionPresent

value: false

Criteria reviewed in determining serious adverse event

url

criterionCode

value: Other Medically Important Condition (NCI Thesaurus#C82521)

url

criterionPresent

value: false

Criteria reviewed in determining serious adverse event

url

criterionCode

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

url

criterionPresent

value: false

status: completed

actuality: actual

category: Device (AdverseEventCategory#device)

code: 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"

occurrence: 2020-05-20 --> (ongoing)

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

seriousness: Serious (AdverseEventSeriousness#serious)

outcome: Fatal (NCI Thesaurus#C48275)

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

Participants

-FunctionActor
*authenticator (ParticipationType#AUTHEN)Practitioner/practitioner-owen-oncologist " ONCOLOGIST"

study: ResearchStudy/clinical-trial-example-compass

expectedInResearchStudy: false

suspectEntity

instance: Device/device-infuser

Causalities

-EntityRelatedness
*Related (NCI Thesaurus#C53260)

suspectEntity

instance: MedicationAdministration/medication-administration-kadcyla1

Causalities

-EntityRelatedness
*Not Related (NCI Thesaurus#C53256)

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

Source1

{
  "resourceType": "AdverseEvent",
  "id": "adverse-event-device-death",
  "meta": {
    "profile": [
      "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/AdverseEvent-clinical-research"
    ]
  },
  "text": {
    "status": "extensions",
    "div": "<!-- snip (see above) -->"
  },
  "extension": [
    {
      "url": "http://hl7.org/fhir/uv/ae-research-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-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-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-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-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-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-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-ig/StructureDefinition/seriousness-criteria"
    }
  ],
  "status": "completed",
  "actuality": "actual",
  "category": [
    {
      "coding": [
        {
          "system": "http://terminology.hl7.org/CodeSystem/adverse-event-category",
          "code": "device",
          "display": "Device"
        }
      ]
    }
  ],
  "code": {
    "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"
  },
  "occurrencePeriod": {
    "start": "2020-05-20"
  },
  "resultingEffect": [
    {
      "display": "Condition with Deep puncture wound (disorder) - SNOMED CT code. Note this different than the AdverseEvent.code in this instance."
    }
  ],
  "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"
  },
  "participant": [
    {
      "function": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/v3-ParticipationType",
            "code": "AUTHEN"
          }
        ]
      },
      "actor": {
        "reference": "Practitioner/practitioner-owen-oncologist"
      }
    }
  ],
  "study": [
    {
      "reference": "ResearchStudy/clinical-trial-example-compass"
    }
  ],
  "expectedInResearchStudy": false,
  "suspectEntity": [
    {
      "instanceReference": {
        "reference": "Device/device-infuser"
      },
      "causality": {
        "entityRelatedness": {
          "coding": [
            {
              "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
              "code": "C53260",
              "display": "Related"
            }
          ]
        }
      }
    },
    {
      "instanceReference": {
        "reference": "MedicationAdministration/medication-administration-kadcyla1"
      },
      "causality": {
        "entityRelatedness": {
          "coding": [
            {
              "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
              "code": "C53256",
              "display": "Not Related"
            }
          ]
        }
      }
    }
  ],
  "note": [
    {
      "text": "During infusion of kadcyla an infuser exploded, shrapnel from the explosion caused a fatal puncture wound."
    }
  ]
}