BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 10635718 · Received October 6, 2020

    Report

    Report Number
    2016493-2020-18346
    Event Type
    Malfunction
    Date Received
    October 6, 2020
    Report Date
    September 10, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    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 FOR SN (B)(4) WAS PERFORMED FROM DATE OF MANUFACTURE 06/04/2012 TO PRESENT DATE 10/05/2020,AND NOTE THAT THIS DEVICE HAS BEEN RETURNED FOR SERVICE ONCE WITHOUT CORRELATION TO THE CUSTOMER REPORTED ISSUE. ALSO, THERE WERE NO PRODUCTION FAILURES INDICATED ON THE SOURCE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE RECEIVED AN ERROR CODE 210.6040. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103437 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1