BEUDAMED
    FDA Adverse Event Other Summary report: N

    ELASTOMERIC PUMP (HOME PUMP C-SERIES)

    MDR report key: 17005295 · Received May 24, 2023

    Report

    Report Number
    MW5117878
    Event Type
    Other
    Date Received
    May 24, 2023
    Manufacturer
    AVENT S. DE R.L. DE C.V.
    Product Code
    MEB
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PATIENT (B)(6) IS SCHEDULED TO RECEIVE AN AT HOME INFUSION IS 5-FU WITH AN ELASTOMERIC PUMP (HOME PUMP C-SERIES). THE PATIENT DID NOT KNOW THE CORRECT POSITIONING OF THE PUMP FROM THE CATHETER SITE. IT IS RECOMMENDED THAT THE PUMP BE PLACES APPROXIMATELY 40 CM (16 IN) BELOW THE CATHETER SITE. THE PATIENT WAS PLANNING TO POSITION THE PUMP ABOVE THIS LEVEL WHICH COULD HAVE CAUSED AN INCREASED FLOW RATE IN THE MEDICATION. INCREASING THE FLOW RATE OF THIS MEDICATION COULD HAVE CAUSED VARIOUS ADVERSE EFFECTS FOR THE PATIENT. STRATEGIES TO MITIGATE THESE RISKS INCLUDE HAVING A TRAINED HOME NURSE THERE FOR THE INFUSION TO ENSURE THAT THE PUMP IS POSITIONED AND PREPARED APPROPRIATELY. THERE COULD ALSO BE EXTENSIVE PATIENT TRAINING ON THESE DEVICES AS WELL. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1576579 ELASTOMERIC PUMP (HOME PUMP C-SERIES) PUMP, INFUSION, ELASTOMERIC MEB AVENT S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown