BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8015 ALARIS SYSTEM PC UNIT

    MDR report key: 11249755 · Received January 29, 2021

    Report

    Report Number
    2016493-2021-20479
    Event Type
    Malfunction
    Date Received
    January 29, 2021
    Report Date
    July 8, 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 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 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). CASE DESCRIPTION: CUSTOMER RECEIVES SYSTEM ERROR AT POWER ON FOR 8015 (S/N 14329518). FAILURE DEVICE TYPE: FAILURE PROBLEM TYPE: FAILURE MODE: CASE RESOLUTION: CUSTOMER RECEIVES SYSTEM ERROR AT POWER ON FOR 8015 (S/N (B)(4)). EXPLAINED PROBLEMATIC ISSUE FOR ERROR TO OCCUR AT DEVICE POWERING ON. IDENTIFIED PROBABLE CAUSE RELATED TO THE POLO MIX MATCH FROM THE SOFTWARE. CUSTOMER TO RE-FLASH THE POLO SOFTWARE ONTO THE LOGIC BOARD. IF PROBLEM NOT RESOLVED, CUSTOMER TO REPAIR/REPLACE THE LOGIC BOARD. ASSISTED CUSTOMER TO IDENTIFY FILES NEEDED TO TRANSFER TO COMPACT FLASH CARD. CUSTOMER TO CALL BACK FOR ASSISTANCE IF ANY FURTHER ISSUES AND/OR CONCERNS NEED ADDRESSING. END CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148405 8015 ALARIS SYSTEM PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1