BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASY PUMP

    MDR report key: 23757190 · Received December 8, 2025

    Report

    Report Number
    MW5180155
    Event Type
    Malfunction
    Date Received
    December 8, 2025
    Date of Event
    December 2, 2025
    Report Date
    December 3, 2025
    Manufacturer
    FIRST MEDICAL SOURCE, LLC
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I RECEIVE TREATMENT FOR PANCREATIC CANCER AT THE (B)(6) IN (B)(6). THEY RECENTLY BEGAN USING A DIFFERENT PUMP TO DELIVER 98.4 ML OF FLUOROURACIL, WHICH I WOULD WEAR FOR TWO DAYS. DURING MY LAST CYCLE I NOTICED THE PUMP STILL SEEMED LIKE THERE WAS A CONSIDERABLE AMOUNT OF FLUID REMAINING WHEN IT WAS REMOVED. I AM REPORTING THIS NEW PUMP, BRAND NAME "INFULLIFE - EASY PUMP" BECAUSE IT DOESN'T MEASURE UP TO THE SAME STANDARD AS THE PREVIOUS DEVICE. I DON'T WANT TO HAVE TO WEAR THIS PUMP ANY LONGER THAN I NEED TO, NOR DO I WANT TO BE DENIED THE FULL DOSAGE OF MY TREATMENT. I HAVE SPOKEN WITH MY PROVIDER REGARDING THIS MATTER, AS HAVE OTHER PATIENTS, BUT I THINK IT IS IMPORTANT TO GET THE WORD OUT SO THAT THE FDA IS AWARE OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1990376 EASY PUMP PUMP, INFUSION, ELASTOMERIC MEB FIRST MEDICAL SOURCE, LLC 2509001

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male OLANZAPINE.| PEPTO BISMOL.| URSODIOL.