BEUDAMED
    FDA Adverse Event Death Summary report: N

    VUE RIS

    MDR report key: 3692357 · Received March 11, 2014

    Report

    Report Number
    1317307-2014-00002
    Event Type
    Death
    Date Received
    March 11, 2014
    Date of Event
    February 14, 2014
    Report Date
    March 10, 2014
    Manufacturer
    CARESTREAM HEALTH, INC.
    Product Code
    LLZ
    PMA / PMN Number
    CLASS1 EX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CARESTREAM HEALTH SERVICE PERSONNEL CONDUCTED AN INVESTIGATION OF THIS ISSUE TO DETERMINE HOW THE VUE RIS WAS WORKING DURING THE EVENT. THE INVESTIGATION INCLUDED COLLECTION OF LOGS SHOWING ALL OF THE MESSAGES REC'D BY THE HOSPITAL'S VUE RIS FROM THEIR SENDING SYSTEM (3RD PARTY VENDOR). THE VUE RIS CONTAINS THE PT INFO SENT BY THE USER THROUGH THEIR 3RD PARY SYSTEM. THE LOG SHOW TWO (2) TYPES OF MESSAGES REC'D BY THE VUE RIS; ORM (ORDERS) AND ADT. THE ORM MESSAGES FROM THE HOSPITAL CONTAIN PT INFO, INCLUDING ALLERGY INFO. THE HOSPITAL DOES NOT ENTER ALLERGY INFO IN ADT MESSAGES. THE ORDER IN WHICH VUE RIS RECEIVES THE MESSAGES IS IMPORTANT; THE LAST MESSAGE REC'D IS CONSIDERED THE MASTER AND LATEST UPDATE ON THE PT. LOG SHOW THE ALLERGY INFO TRANSMITTED FROM THE HOSPITAL SYSTEM TO THE VUE RIS IN THE ORM MESSAGE FOR THIS PT ON (B)(6) 2014. THE LOGS SHOW A USER AT THE HOSPITAL SENT AN ADT MESSAGE DISCHARGING THE PT; THIS ADT MESSAGE DID NOT INCLUDE ALLERGY INFO BECAUSE THAT INFO IS NOT INCLUDED IN ADT MESSAGES. ALLERGY INFO WAS CURRENT IN VUE RIS FOR THE PT AS OF THE LAST STUDY PERFORMED ((B)(6) 2014:16:30). THE VUE RIS REC'D A PT DISCHARGE NOTIFICATION (ADT_A03) FROM THE HOSPITAL'S ORDERING SYSTEM AT ((B)(6) 2014:14:17) THAT DID NOT CONTAIN THE ALLERGY INFO. AFTER (B)(6) 2014, THE VUE RIS REC'D A SERIES OF PT UPDATE (ADT_A08) MESSAGES; AGAIN THESE MESSAGES DID NOT CONTAIN ANY ALLERGY INFO.

    Description of Event or Problem · 1

    ON (B)(6) 2014, CARESTREAM HEALTH REC'D AN INQUIRY REGARDING AVAILABILITY OF PT ALLERGY INFO IN VUE RIS. CARESTREAM WAS INFORMED THAT THE (B)(6) YR OLD ONCOLOGY PT HAD PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146372 VUE RIS RADIOLOGY INFORMATION SYSTEM (RIS) LLZ CARESTREAM HEALTH, INC. VERSION 11.0.12.

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death