BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD ALARIS INFUSION SYSTEM PUMP

    MDR report key: 19511806 · Received June 10, 2024

    Report

    Report Number
    MW5156114
    Event Type
    Other
    Date Received
    June 10, 2024
    Date of Event
    March 28, 2024
    Report Date
    June 6, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY
    Product Code
    FRN
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHEN MEDICATION STRENGTH WAS CHANGED FROM SINGLE STRENGTH (20MG/250ML) TO QUAD (80MG/250ML) AND QUINTUPLE (100MG/250ML) STRENGTH, THERE WAS A DISCREPANCY BETWEEN THE IV PUMP DISPLAYED RATE/DOSE AND THE ACTUAL RATE/DOSE. IV PUMP BEING USED INDICATED DELIVERING 1.9MCG/KG/MIN TO 2.1MCG/KG/MIN OF PHENYLEPHRINE, BUT IN REALITY, THE DOSE RECEIVED WAS BETWEEN 8.5MCG/KG/MIN TO 9.5MCG/KG/MIN. PUMP DISPLAY DIDN'T MATCH WHAT AUTOMATICALLY DOCUMENTED ON TO THE MEDICATION ADMINISTRATION RECORD OR THE IAWARE PACKAGE THAT SIGNS THE RESULT ONTO THE MEDICATION ADMINISTRATION RECORD. ABLE TO CONFIRM INCORRECT RATE BY THE IV BAG EMPTYING IN 1 HOUR AND 45 MINUTES INSTEAD OF OVER SEVERAL HOURS. HEALTH TECHNOLOGY MANAGEMENT DIRECTOR, NURSING, AND RISK MANAGEMENT PERFORMED TESTS WITH THE PUMP IN QUESTION AND WITH OTHER PUMPS AND WERE ABLE TO REPLICATE THE ERROR UNDER A SPECIFIC SET OF CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189530 BD ALARIS INFUSION SYSTEM PUMP PUMP, INFUSION FRN BECTON, DICKINSON AND COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male