BEUDAMED
    FDA Adverse Event Other Summary report: N

    C-SERIES ECLIPSE PUMP

    MDR report key: 17288470 · Received July 7, 2023

    Report

    Report Number
    MW5119232
    Event Type
    Other
    Date Received
    July 7, 2023
    Date of Event
    June 6, 2023
    Report Date
    July 5, 2023
    Manufacturer
    AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
    Product Code
    MEB
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INCORRECT ECLIPSE PUMP USED TO INFUSE PATIENT; 5FU INFUSED OVER APPROXIMATELY 24HRS, AS OPPOSED TO THE PRESCRIBED 96HRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1687571 C-SERIES ECLIPSE PUMP PUMP, INFUSION, ELASTOMERIC MEB AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) C-SERIES 270ML 5ML/HR

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Other FLUOROURACIL- 06/05/2023-06/06/2023