BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRAVITY FED BALLOON INFUSION DEVICE

    MDR report key: 15892870 · Received December 1, 2022

    Report

    Report Number
    15892870
    Event Type
    Malfunction
    Date Received
    December 1, 2022
    Date of Event
    June 6, 2022
    Report Date
    July 28, 2022
    Product Code
    MBE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A ELDERLY MALE PRESENTED TO THE OUTPATIENT INFUSION CENTER TO BE SET UP FOR 5-FU CHEMO THERAPY USING AN ELASTOMERIC GRAVITY FED INFUSION DEVICE. THE CHEMO WAS INTENDED TO INFUSE AT HOME OVER A 46-HOUR PERIOD. AFTER THE PATIENT GOT HOME HE REALIZED THAT THE ENTIRE 250 ML BALLOON OF CHEMO HAD INFUSED OVER A ONE-HOUR PERIOD INSTEAD OF 46-HOURS. HE RETURNED TO THE HOSPITAL. AN ANTIDOTE TO THE CHEMO AGENT WAS INITIATED WITH THE PLAN TO RETURN DAILY OVER A PERIOD OF A WEEK TO RECEIVE THE EACH DOSE OF THE ANTIDOTE, ALONG WITH IV FLUIDS AND DAILY RE-EXAMINATION BY HIS ONCOLOGIST. UPON REVIEW OF THE EVENT, IT WAS DISCOVERED THAT THE ELASTOMERIC DEVICE WAS UNDER TRIAL AT OUR FACILITY. THE COMPANY REP HAD PROVIDED US WITH 6 ELASTOMERIC DEVICES (SOME FOR CHEMO AND SOME FOR ANTIBIOTICS) SO STAFF COULD BECOME FAMILIAR WITH HOW TO FILL THEM. DUE TO INEXPERIENCE, ONE OF THE ANTIBIOTIC DEVICES (PRE-DETERMINED TO INFUSE OVER ONE HOUR) WAS SELECTED FOR USE INSTEAD OF THE CHEMO DEVICE (PRE-DETERMINED TO INFUSE OVER 46-HOURS). WE REQUEST THE MANUFACTURER TO CONSIDER EITHER MAKING THE DIFFERENT DEVICES IN A NEON COLOR, OR TO PRINT IN LARGE BOLD LETTERS WHICH TYPE OF AGENT IS INTENDED FOR WHICH TYPE OF MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2677093 GRAVITY FED BALLOON INFUSION DEVICE MBE

    Patients

    Seq Age Sex Outcome Treatment
    1 21170 DA Male