BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 11516566 · Received March 18, 2021

    Report

    Report Number
    3012307300-2021-01776
    Event Type
    Malfunction
    Date Received
    March 18, 2021
    Date of Event
    January 22, 2021
    Report Date
    March 18, 2021
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT THE CADD PRIZM VIP PUMP CAUSED UNDER INFUSION. THE PUMP WAS UNABLE TO BE RE-STARTED AT THE INFUSION CENTER. THE PUMP STATES ?NO RATE PROGRAMED", ?RATE OF 1ML PER HR", ?0 ML INFUSED." THE CHEMOTHERAPY BAG WEIGHED 196 ML INCLUDING WEIGHT OF BAG, SO LITTLE 5FU INFUSED. THE PATIENT WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409703 CADD PUMP, INFUSION FRN

    Patients

    Seq Age Sex Outcome Treatment
    1