BEUDAMED
    FDA Adverse Event Death Summary report: N

    MCKESSON RADIOLOGY

    MDR report key: 8220473 · Received January 5, 2019

    Report

    Report Number
    8022257-2018-00002
    Event Type
    Death
    Date Received
    January 5, 2019
    Date of Event
    December 5, 2018
    Report Date
    January 4, 2019
    Manufacturer
    CHANGE HEALTHCARE CANADA COMPANY
    Product Code
    LLZ
    UDI-DI
    17540262020014
    PMA / PMN Number
    K140909
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CHANGE HEALTHCARE'S CUSTOMER SUPPORT TEAM SUCCESSFULLY LOCATED THE IMAGING STUDY FOR THE PATIENT IN MCKESSON RADIOLOGY PACS. UPON FURTHER INVESTIGATION, CHANGE HEALTHCARE'S CUSTOMER SUPPORT TEAM DETERMINED THAT THE STUDY HAD BEEN SENT TO MCKESSON RADIOLOGY FROM AN UPSTREAM SYSTEM WITHOUT AN ASSIGNED MEDICAL RECORD NUMBER (MRN). IN THIS SITUATION, MCKESSON RADIOLOGY PACS IS DESIGNED TO ASSIGN A TEMPORARY MRN USING A DESIGNATED PREFIX UPON IMPORT TO CLEARLY IDENTIFY IMAGING STUDIES NEEDING FURTHER DEMOGRAPHIC REVIEW. USERS ARE EXPECTED TO IDENTIFY AND UPDATE THE TEMPORARY MRN FIELD DURING THE REVIEW WORKFLOW FOLLOWING IMPORT OF AN IMAGING STUDY. MCKESSON RADIOLOGY PACS PROVIDES ADDITIONAL FEATURES TO ENABLE USERS TO SEARCH FOR AND LOCATE IMAGING STUDIES IN THE SYSTEM USING DIFFERENT METHODS; FOR EXAMPLE, BY USING THE ACCESSION NUMBER SEARCH OR USING THE "RECENTLY PERFORMED" STUDY LIST FILTER. MCKESSON RADIOLOGY PACS PERFORMED AS DESIGNED.

    Description of Event or Problem · 1

    THE REPORTING FACILITY CONTACTED CHANGE HEALTHCARE'S CUSTOMER SUPPORT TEAM TO DETERMINE WHETHER AN IMAGING STUDY PERFORMED FOR AN EMERGENCY PATIENT HAD BEEN IMPORTED INTO MCKESSON RADIOLOGY PACS FROM THE MODALITY, AS THE REPORTING FACILITY HAD BEEN UNABLE TO LOCATE THE STUDY IN THE SYSTEM. THE REPORTING FACILITY INDICATED THE PATIENT HAD SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13158 MCKESSON RADIOLOGY PICTURE ARCHIVING AND COMMUNICATION SYSTEM LLZ CHANGE HEALTHCARE CANADA COMPANY 12.3 17540262020014

    Patients

    Seq Age Sex Outcome Treatment
    1 Death