BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFUSION (BD)

    MDR report key: 7344738 · Received March 15, 2018

    Report

    Report Number
    MW5075908
    Event Type
    Malfunction
    Date Received
    March 15, 2018
    Date of Event
    March 9, 2018
    Report Date
    March 14, 2018
    Manufacturer
    CAREFUSION (BD)
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ALARIS CAREFUSION PUMPS HAVE CONTINUED TO HAVE ISSUES DELIVERING CONTINUOUS INFUSIONS OR LONGER INFUSIONS FOR CHEMOTHERAPY. THIS HAS BECOME MORE EVIDENT WITH EXACT DOSE AND PROGRAMMING DONE FOR CHEMOTHERAPY AGENTS, LIKE DOXORUBICIN. IN THIS PARTICULAR EVENT: A CONTINUOUS 24 HOUR DOXORUBICIN INFUSION RATE HAD TO BE INCREASED BY APPROXIMATELY DOUBLE FOR THE LAST 2 HOURS IN ORDER TO FINISH ON TIME PER CHEMOTHERAPY ROAD MAP. THE VOLUME TO BE INFUSED (VTBI) ON THE PUMP DID NOT MATCH THE ACTUAL AMOUNT LEFT IN THE BAG. THIS IS ONE OF 8 EXAMPLES OF THIS OCCURRING, WITHOUT RESOLUTION FROM THE COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183501 CAREFUSION (BD) ALARIS FRN CAREFUSION (BD) 8015

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Other