BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD ALARIS PUMP

    MDR report key: 18563764 · Received January 22, 2024

    Report

    Report Number
    MW5150631
    Event Type
    Other
    Date Received
    January 22, 2024
    Report Date
    January 22, 2024
    Manufacturer
    BD/CAREFUSION 303, INC.
    Product Code
    FRN
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THERE IS A POTENTIAL ERROR WHEN UTILIZING BD ALARIS PUMPS FOR PENICILLIN G INFUSION FOR PEDIATRIC PATIENTS UTILIZING THE SYRINGE MODULE. THE CURRENT ALARIS BUILD ONLY ALLOWS FOR 5 CHARACTERS TO BE ENTERED INTO THE DOSE FIELD, BUT OFTEN DOSES REQUIRE 6 CHARACTERS. THIS RESULTS IN INSTITUTIONS CREATING WORK AROUNDS, SUCH AS CLINICAL ALERTS INDICATING 1 UNIT= 1000 UNITS, CONVERTING UNITS TO MG OR ML, UTILIZING BASIC INFUSION WITHOUT GUARDRAILS, AND/OR NOT UTILIZING INTEROPERABILITY FEATURES OF THE PUMP AND EMR. REVIEWING WHAT INSTITUTIONS ARE DOING IN PRACTICE, THERE IS NO STANDARD, AND THE MANUFACTURER (BD) HAS NOT PROVIDED ANY UPDATE AS TO IF THERE IS AN ANTICIPATED CHANGE OR UPDATE TO THE MODULES. AS OF CURRENT, BD INDICATES THAT PENICILLIN G IS NOT COMPATIBLE WITH THE PUMP AND PROVIDES NO GUIDANCE ON HOW TO PROCEED. THE PUMP IS ALSO LIMITED BY NOT PROVIDING MILLION UNITS / KG OR ML/KG AS A DOSING UNIT. ISMP, 5200 BUTLER PIKE, PLYMOUTH MEETING, PA 19462, PHONE: 215-947-7797, EMAIL: [email protected]. SUBMISSION ID: 88383.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1953774 BD ALARIS PUMP PUMP, INFUSION FRN BD/CAREFUSION 303, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown PENICILLIN G INFUSION.| SYRINGE MODULE.