BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8015 ALARIS SYSTEM PC UNIT

    MDR report key: 11264581 · Received February 2, 2021

    Report

    Report Number
    2016493-2021-22289
    Event Type
    Malfunction
    Date Received
    February 2, 2021
    Report Date
    April 29, 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). THERE IS NO PATIENT INVOLVEMENT. 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: EMAIL WITH REGARDS OF 8015 UNITS HAVING 800.8000 ERRORS. SN: (B)(4). CASE RESOLUTION: CONTACTED (B)(6) AND WENT OVER KA 11775 ALARIS INFUSION MEDICAL SAFETY NOTIFICATION MODEL 8015 SYSTEM ERROR 255-16-275 - 800.8000 WITH HER. EMAILED HER AS WELL THE SAFETY NOTIFICATION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161947 8015 ALARIS SYSTEM PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1