BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 10282855 · Received July 16, 2020

    Report

    Report Number
    2016493-2020-01774
    Event Type
    Malfunction
    Date Received
    July 16, 2020
    Report Date
    June 26, 2020
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE WILL BE RETURNED PER CUSTOMER. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE DEVICE WAS NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED. ALTHOUGH REQUESTED, FURTHER INFORMATION WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED DEVICE OVER INFUSED AN UNKNOWN MEDICATION OR FLUID. THE CUSTOMER CALLED BD TECH SERVICE OVER A POOR PHONE CONNECTION AND STATED THAT "ALLEGED 2 G/HR WITH BOLUS OF 4G/HR AND IN HALF HOUR DELIVERED 16G." ALTHOUGH REQUESTED, FURTHER INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750527 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1