BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8015 ALARIS SYSTEM PC UNIT

    MDR report key: 10866969 · Received November 19, 2020

    Report

    Report Number
    2016493-2020-43783
    Event Type
    Malfunction
    Date Received
    November 19, 2020
    Report Date
    June 14, 2018
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTED EVENT AND SUBSEQUENT REPAIRS WERE INVESTIGATED THROUGH THE TSC TROUBLESHOOTING PROCESS. A REVIEW OF THE DEVICE SERVICE HISTORY RECORD WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE CORRESPONDING TO THIS SERVICE NOTIFICATION NUMBER. THE DATABASE SHOWED NO QUALITY NOTIFICATIONS WERE OPENED FOR THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR SN (B)(4) WAS PERFORMED FROM THE DATE OF THE MANUFACTURE TO DATE OF THE RELEASE OF PRODUCT, WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE, AND PRODUCT WAS NOT RETURNED FOR SERVICING WHICH NOT CORRELATES TO THE CUSTOMER REPORTED ISSUE. A TRACKWISE COMPLAINT HISTORY REVIEW WAS COMPLETED, AND IT WAS CONFIRMED THAT THERE WERE ADDITIONAL COMPLAINTS RECEIVED WITH SIMILAR SN (B)(4) FOR THE SAME OR RELATED FAILURE MODE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    (B)(4). 8015 UNIT. SERIAL # (B)(4). CUSTOMER CALLED IN WITH ERROR CODE 13-1033-146 ON 8015 UNIT WHICH IS A SOFTWARE FAULT ERROR THE SOFTWARE ON THE UNIT IS CORRUPT NEEDS TO REFLASH SOFTWARE, BUT IF THE REFLASH FAILS, THEN THE LOGIN BOARD WHICH IS THE MAIN BOARD HAS TO BE REPLACE. CUSTOMER ALSO RAN THE ERROR REPORT ON THE UNIT AND SEEN ALOT OF CALL STACK DATA ERRORS WHICH THOSE ERRORS RELATE TO THE SOFTWARE FAULT ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1333356 8015 ALARIS SYSTEM PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1