BEUDAMED
    FDA Adverse Event Death Summary report: N

    BD CAREFUSION ALARIS SMARTPUMP INFUSION PUMP

    MDR report key: 16311892 · Received February 7, 2023

    Report

    Report Number
    MW5114724
    Event Type
    Death
    Date Received
    February 7, 2023
    Date of Event
    October 20, 2022
    Report Date
    February 3, 2023
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FRN
    Report Source
    Voluntary report
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FOLLOWING A SMART PUMP PROGRAMMING ERROR, PATIENT RECEIVED 1000MG OF IV ACETAMINOPHEN INSTEAD OF THE ORDERED 175MG (15 MG/KG). THE RN HUNG 1000MG/100ML IV ACETAMINOPHEN IN MANUFACTURER'S VIAL. THE PUMP ASKED FOR DRUG AMOUNT, INPUT WAS 175MG; DILUENT VOLUME, INPUT WAS 100ML (TOTAL VOLUME IN THE VIAL RATHER THAN THE VTBI 17.5ML), AND WEIGHT 11.4 KG. THE RN BYPASSED A SOFT ALERT THAT READ "CONCENTRATION IS BELOW GUARDRAILS LIMIT OF 9 MG/ML. PROCEED?". WE HAVE CONCERNS ABOUT TWO PARTS OF THIS THAT BD DECLINED TO ADDRESS. DILUENT VOLUME IN THIS CASE IS CONFUSING - THE RN DID HANG 100ML. WE ASKED THIS TO BE CHANGED TO VTBI. MORE URGENTLY, THE CONCENTRATION IS BELOW GUARDRAIL LIMITS IS A COUNTERINTUITIVE ALERT. I INTERVIEWED SEVERAL RNS AND ALL BELIEVED THIS WARNING WOULD RESULT IN AN UNDERDOSE TO THE PATIENT, WHEN IN FACT IT CAUSES OVERDOSE. WHILE THE LANGUAGE IS NOT INCORRECT, WE WOULD ASK FOR ADDITIONAL CLARITY AROUND THE RISKS OF INFUSING A LOW CONCENTRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81471 BD CAREFUSION ALARIS SMARTPUMP INFUSION PUMP PUMP, INFUSION FRN CAREFUSION 303, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Male Death IV ACETAMINOPHEN 10/20/2022-10/23/2022