BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTA BIOMEDICAL SYRINGE INFUSION PUMP

    MDR report key: 17994951 · Received October 24, 2023

    Report

    Report Number
    17994951
    Event Type
    Malfunction
    Date Received
    October 24, 2023
    Date of Event
    August 15, 2023
    Report Date
    September 26, 2023
    Manufacturer
    ATLANTA BIOMEDICAL CORPORATION
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHEN UTILIZING THE ATLANTA BIOMEDICAL CORPORATION SYRINGE INFUSION PUMP MODEL 4100 TO ADMINISTER A SYRINGE FEEDING TO PATIENT, THE INFUSION PUMP INCORRECTLY STOPPED THE INFUSION WITH A MESSAGE THAT THE SYRINGE IN USE WAS EMPTY. THE SYRINGE USED WAS NOT EMPTY, SO RN CLEARED THE ERROR MESSAGE AND STARTED THE INFUSION AGAIN. MINUTES LATER, RN RECHECKED THE PUMP TO SEE THAT IT HAD EXCEEDED ITS PROGRAMMED TOTAL VOLUME TO INFUSE BY 0.63 ML AND WAS CONTINUING TO INFUSE WITHOUT SHUTTING OFF. THE PUMP WAS MANUALLY TURNED OFF BY RN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1583788 ATLANTA BIOMEDICAL SYRINGE INFUSION PUMP PUMP, INFUSION FRN ATLANTA BIOMEDICAL CORPORATION 4100

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown