BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFULIFE INFUSION PUMP

    MDR report key: 23731108 · Received December 5, 2025

    Report

    Report Number
    MW5180044
    Event Type
    Malfunction
    Date Received
    December 5, 2025
    Date of Event
    December 1, 2025
    Report Date
    December 1, 2025
    Manufacturer
    FIRST MEDICAL SOURCE, LLC
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PART OF CHEMO TREATMENT IS PORTABLE INFUSION PUMP. RECENTLY THEY SWITCHED TO INFULIFE 270 ML -5ML/HR PUMP. NURSES REPORT THAT MOST PUMPS NOT DRAINING AS REQUIRED/FULLY. PATIENTS ARE BEING GIVEN EXTRA INSTRUCTIONS TO ENSURE FULL VOLUME DELIVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2423000 INFULIFE INFUSION PUMP PUMP, INFUSION, ELASTOMERIC MEB FIRST MEDICAL SOURCE, LLC (10) 2509001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other