BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP ELASTOMERIC INFUSION PUMP

    MDR report key: 23630924 · Received November 24, 2025

    Report

    Report Number
    MW5179327
    Event Type
    Malfunction
    Date Received
    November 24, 2025
    Date of Event
    November 17, 2025
    Report Date
    November 19, 2025
    Manufacturer
    B. BRAUN MEDICAL INDUSTRIES SDN. BHD.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I WAS PREPARING A FLUOROURACIL PUMP USING THE EASYPUMP, A 270 ML CAPACITY ML/HR, 54 HR PUMP. AFTER INJECTING AROUND 140 ML OF NORMAL SALINE, I ATTACHED THE ONGUARD 2 CSTD LUER LOCK ADAPTOR AND BEGAN INJECTING AROUND 94 ML OF FLUOROURACIL. AFTER INJECTING APPROXIMATELY 20 MLS OF 5-FU THE DRUG BEGAN TO LEAK FROM WHERE THE SYRINGE AND ADAPTOR WERE ATTACHED. THERE WAS A SLOW DRIP AND APPROXIMATELY 2 MLS LEAKED FROM THE PUMP. I REMOVED THE ONGUARD ADAPTOR AND REPLACED IT WITH A NEW ONE AND THE PUMP CONTINUED TO LEAK. I ALSO ATTEMPTED TO ADD THE DRUG USING A NEW SYRINGE AND ONGUARD SYRINGE ADAPTOR, BUT THE PUMP CONTINUED TO LEAK WHENEVER I ATTEMPTED TO INJECT MORE DRUG. THIS WAS ACTUALLY THE SECOND TIME THIS HAS OCCURRED FOR ME WITH AN EASYPUMP. BOTH TIMES WERE NEARLY IDENTICAL, AFTER PRIMING WITH 10 MLS OF SALINE AND INJECTING ABOUT 150 MLS OF SALINE AND 20 MLS OF 5-FU THE PUMP BEGAN TO LEAK FROM THE DRUG INJECTION SITE. BOTH TIMES I ATTEMPTED TO CONTINUE THE PREPARATION WITH NEW ADAPTORS AND SYRINGES, BUT EACH TIME I ATTEMPTED TO ADD MORE DRUG MORE WOULD LEAK OUT. I DIDN'T SAVE THE FIRST PUMP PACKAGING, BUT I DID SAVE THE SECOND. REFERENCE REPORT# MW5179328. PT CODE: 4582. DEVICE CODE: 1354.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314692 EASYPUMP ELASTOMERIC INFUSION PUMP PUMP, INFUSION, ELASTOMERIC MEB B. BRAUN MEDICAL INDUSTRIES SDN. BHD. II LT 270-54-S 25C23GE561

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown