BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDELA NICU FEEDING PUMP

    MDR report key: 11595925 · Received March 30, 2021

    Report

    Report Number
    MW5100416
    Event Type
    Malfunction
    Date Received
    March 30, 2021
    Date of Event
    February 18, 2021
    Report Date
    March 26, 2021
    Manufacturer
    ATLANTA BIOMEDICAL CORPORATION / ELIXIR CORPORATION
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MEDELA FEEDING PUMP WAS PROGRAMMED TO RUN 28ML OF FEED OVER 2 HOURS. AT THE END OF 2 HOURS, 16ML REMAINED IN FEEDING SYRINGE. NNP NOTIFIED, PUMP SWITCHED OUT, REMAINDER OF FEED GIVEN OVER APPROPRIATE TIME. PUMP SENT TO BIOMED. PUMP # 22707. BIOMED COMPLETED THE EXAMINATION AND TEST OF THE MEDELA ENTERAL PUMP. THE PUMP PASSED ALL TESTS. IN ADDITION TO THESE TESTS WHICH ARE DIRECTLY FROM THE MANUFACTURER SERVICE MANUAL, I TESTED THE PUMP FOR RATE/ VOLUME/ TIME WHICH MATCHED THE INFORMATION FROM THE INCIDENT. THE PUMP PERFORMED AS PROGRAMMED FOR THIS TEST WHICH WAS RUN TWICE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490128 MEDELA NICU FEEDING PUMP PUMP, INFUSION FRN ATLANTA BIOMEDICAL CORPORATION / ELIXIR CORPORATION 4100

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR