BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM PC UNIT

    MDR report key: 10659963 · Received October 10, 2020

    Report

    Report Number
    2016493-2020-19450
    Event Type
    Malfunction
    Date Received
    October 10, 2020
    Report Date
    September 21, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K091308
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORTED PROBLEM WAS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(4) WAS PERFORMED FROM DATE OF MANUFACTURE 05/07/2014 TO THE PRESENT DATE 10/7/2020 AND CONFIRMED THAT THIS DEVICE WAS NOT PREVIOUSLY RETURNED FOR SERVICING AND THERE WERE PRODUCTION FAILURES (B)(4) FOR WRONG PKB WHICH DOES NOT CORRELATE TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE RECEIVED ERROR CODE 800.8000. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1124505 ALARIS SYSTEM PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1