BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALARIS PUMP

    MDR report key: 17825955 · Received September 26, 2023

    Report

    Report Number
    MW5146194
    Event Type
    Other
    Date Received
    September 26, 2023
    Report Date
    September 22, 2023
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FRN
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    REVIEW OF PUMP PROGRAMMING ERRORS FROM XXXXXX HEALTH CARE SYSTEM WIDE FOUND SEVERAL CONTINUOUS IV DOSING ERRORS WHERE THE DOSE WAS PROGRAMMED INTO THE RATE FIELD OF THE ALARIS PUMP RESULTING IN A WRONG DOSE. (E.G., O FENTANYL 25 MCG/HR DOSE ENTERED AS 25 ML/HR, RESULTING IN A TOO HIGH DOSE OF 250 MCG/HR. O NICARDIPINE 2.5 MG/HR DOSE ENTERED AS 2.5 ML/HR RESULTING IN A TOO LOW DOSE OF 0.25 MG/HR.) *ASK ALARIS TO GREY OUT THE RATE FIELD FOR GUARDRAIL MEDICATIONS AND ONLY ALLOW USE WHEN PROGRAMMING GUARDRAIL FLUIDS OR DEVELOP AN ALERT SIMILAR TO THE NEW ONE TO REMIND DOSES TO UNCLAMP SECONDARIES WHEN THE RATE FIELD IS USED TO PROGRAM THE PUMP. REINFORCE SAFE PROGRAMMING PRACTICES THROUGH EDUCATION AND SIMULATIONS. REINFORCE HRO TOOLS INCLUDING CROSS MONITORING AND STAR DEVELOP SOFT ALERTS TO PREVENT INCORRECT PROGRAMMING BUT ALSO AVOID NUISANCE ALERTS. (E.G., FENTANYL SOFT MAX TO 249 MCG/HR AND WILL ALERT IF RATE OF 25 ML/HR (250 MCG/HR) IS PROGRAMMED. NICARDIPINE SOFT MIN ALERT TO 0.5 MG/HR AND WILL ALERT IF 2.5 ML/HR (0.25 MG/HR) IS PROGRAMMED. ISMP, (B)(4). SUBMISSION ID: (B)(4). SUBMITTED DATE: 08/14/2023. REFERENCE REPORT: #MW5146193.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1100019 ALARIS PUMP PUMP, INFUSION FRN CAREFUSION 303, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown FENTANYL.| NICARDIPINE HCL.