BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CAREFUSION

    MDR report key: 13548440 · Received February 17, 2022

    Report

    Report Number
    13548440
    Event Type
    Malfunction
    Date Received
    February 17, 2022
    Date of Event
    February 2, 2022
    Report Date
    February 7, 2022
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    IV PUMP WAS RINGING OFF OCCLUDED REPEATEDLY. THE IV ITSELF WAS FUNCTIONING WITHOUT ISSUE. THEY OPENED THE PUMP TO SEE IF THERE WAS AN ISSUE THERE AND FOUND THAT THE SOFT SECTION OF THE TUBING THAT FITS IN THE PUMP HAD BALLOONED UP. WHEN THEY REPLACED THE TUBING THERE WERE NO FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998010 BD CAREFUSION SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 303, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown