BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELASTOMERIC INFUSION PUMP

    MDR report key: 23768589 · Received December 10, 2025

    Report

    Report Number
    MW5180246
    Event Type
    Injury
    Date Received
    December 10, 2025
    Date of Event
    October 29, 2025
    Report Date
    November 3, 2025
    Manufacturer
    AVANOS MEDICAL, INC.
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    REPORT: 1845777: LLT CODES: 10069327; PRODUCT QUALITY ISSUE I NARRATIVE: PHARMACY TECHNICIAN FILLING AVANOS ELASTOMERIC PUMP 5 ML/HR, 270ML, VOLUME LOT #30281615 EXPERIENCED INABILITY TO TRANSFER NORMAL SALINE FROM A SYRINGE INTO THE PUMP. TRANSFER WAS MET WITH RESISTANCE/BACKPRESSURE. SUBSEQUENTLY, THE TECHNICIAN ABANDONED THE PROBLEM ELASTOMERIC PUMP AND RETRIEVED ANOTHER (FROM THE SAME LOT) AND THE TRANSFER OCCURRED WITHOUT ISSUE. SUBSEQUENT TO THIS EVENT WE SEQUESTERED ALL OF THIS LOT (3 PUMPS TOTAL). ONE OF THEM WAS USED/TESTED AND FOUND TO WORK FINE. SEEMS THIS MAY BE AN INTRA-LOT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2876403 ELASTOMERIC INFUSION PUMP PUMP, INFUSION, ELASTOMERIC MEB AVANOS MEDICAL, INC. 30281615

    Patients

    Seq Age Sex Outcome Treatment
    1 22 MO Female SODIUM CHLORIDE