BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8015 ALARIS SYSTEM PC UNIT

    MDR report key: 11213060 · Received January 22, 2021

    Report

    Report Number
    2016493-2021-14885
    Event Type
    Malfunction
    Date Received
    January 22, 2021
    Report Date
    April 17, 2020
    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

    THE CUSTOMER¿S REPORTED PROBLEM WAS CONFIRMED. 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 REVIEW OF THE COMPLAINT HISTORY RECORD IN THE TRACKWISE WAS PERFORMED FOR THE SN (B)(4) WHICH CONFIRMED NO SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    (B)(4). PATIENT OR USER INVOLVEMENT: NO. PATIENT OR USER HARM: NO. CASE DESCRIPTION: TECH CALLED IN FOR HELP ON ERROR CODE ON 8015 BD UNIT SERIAL # (B)(4). CASE RESOLUTION: TECH IS GET ERROR CODE 810.9030 ON 8015 BD UNIT BEFORE CALL IN TECH TRY TO REFLASH SOFTWARE FAIL, EXPLAIN TO TECH YES THAT IS THE FIRST STEP TO DO BECAUSE ITS THE POLO IS NOT ABLE TO BOOT BECAUSE THE APPLICATION ELF FILE HAS AN INVALID CHECKSUM. , NEXT WOULD BE TO REPLACE IS THE MAIN BOARD ON THE UNIT, TECH PREFER TO SEND UNIT IN FOR REPAIR CONFIRM PRICE QUOTE FOR LEVEL ONE REPAIR. TECH WILL CALL BACK WHEN HE HAS HIS PO# TO SEND UNIT IN FOR REPAIR SERVICES. TECH THANK ME FOR MY ASSIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113042 8015 ALARIS SYSTEM PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1