BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8015 ALARIS SYSTEM PC UNIT

    MDR report key: 11069227 · Received December 23, 2020

    Report

    Report Number
    2016493-2020-79476
    Event Type
    Malfunction
    Date Received
    December 23, 2020
    Report Date
    September 19, 2019
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORTED PROBLEM WAS CONFIRMED. A DHR (DEVICE HISTORY RECORD) REVIEW CANNOT BE COMPLETED AS THE SERIAL NUMBER WAS NOT OBTAINED UPON RECEIPT OF THE COMPLAINT. ADDITIONALLY, A HISTORICAL REVIEW OF COMPLAINTS IN TRACKWISE CANNOT BE CONDUCTED. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    BD QUALITY ADVOCATE, THIS NOTIFICATION IS TO INFORM YOU THAT A NEW CASE HAS BEEN CREATED WITH THE COMPLAINT TYPE CATEGORY INFUSION CA. (B)(4). CASE DESCRIPTION: IT TECH. CALLED IN FOR HELP HE IS UNABLE TO INSTALL GUARDRAIL EDITOR V9.33.1 ON WIN10 . FAILURE DEVICE TYPE: ALARIS SYSTEM INSTRUMENT. FAILURE PROBLEM TYPE: 8015. FAILURE MODE: TROUBLESHOOTING/ ERROR CODES. CASE RESOLUTION: TECH. CALLED IN FOR HELP ON TRY TO GET GUARDRAIL EDITOR SOFTWARE V9.33.1 INSTALL ON WIN10 HE HAS THE BULLETIN 614 TO FOLLOW ON INSTALL E RAN THE INSTALL IN COMPABILIALTY MODE, HE SAVE THE FILES ON HIS DESKTOP AND HE IS USE THE CD TO RUN INSTALL. ERROR HE IS GET ON ALL FOUR PC'S SOFTWARE WILL ONLY INSTALLL ON WINXP OR WIN7 IET TECH. KNOW I WILL DISCUSS THIS ISSUE WITH MY SUPERVISOR AND SOMEONE WILL GET BACK TO HIM. (B)(6). REF: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1531128 8015 ALARIS SYSTEM PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015

    Patients

    Seq Age Sex Outcome Treatment
    1