BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS PC

    MDR report key: 2530648 · Received March 30, 2012

    Report

    Report Number
    2530648
    Event Type
    Death
    Date Received
    March 30, 2012
    Date of Event
    March 8, 2012
    Report Date
    March 29, 2012
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAD BEEN ON REMODULIN THERAPY FOR APPROXIMATELY TWO WEEKS. WHEN THE REMODULIN WAS INITIALLY STARTED, THE NURSE ATTEMPTED TO PROGRAM THE DRIP UTILIZING GUARDRAIL TECHNOLOGY, HOWEVER WHILE PROGRAMMING THE PUMP, THE USER DIDN'T SCROLL DOWN FAR ENOUGH IN THE LIST OF REMODULIN DRUG CONCENTRATIONS AND THUS DIDN'T FIND THE APPROPRIATE "DRUG" TO RUN USING THE PUMPS GUARDRAIL TECHNOLOGIES. THIS ERROR WAS FURTHER COMPOUNDED BY THE FACT THAT IN OUR FACILITY'S DRUG GUIDELINES, WRITTEN AND MAINTAINED BY OUR PHARMACY DEPARTMENT, INACCURATELY ADVISED THE NURSING STAFF TO RUN THE INFUSION AS A "BASIC INFUSION" FOR HIGHER CONCENTRATIONS OF THIS MEDICATION, AS THIS INFUSION WAS. AS A RESULT, THE PUMP WAS PROGRAMMED OUTSIDE OF THE GUARDRAIL FEATURE IN THE ALARIS PUMP AS A BASIC INFUSION. THE PATIENT DID WELL UNTIL MARCH 8TH, AT WHICH TIME HE BECAME HYPOTENSIVE. AS PART OF HIS THERAPY TO CORRECT THE HYPOTENSION, THE PHYSICIAN ORDERED A 500CC FLUID BOLUS OF NORMAL SALINE (NS) TO BE DELIVERED OVER 30 MINUTES. PRIOR TO THE PROGRAMMING OF THE FLUID BOLUS, THE PATIENT WAS ATTACHED TO AN ALARIS PUMP WITH 4 PUMPING CHANNELS ATTACHED TO THE CONTROLLER. ONCE THE ORDER FOR THE NS BOLUS ORDER WAS RECEIVED, THE RN WENT TO THE PUMP AND INSTEAD OF CHOOSING THE NORMAL SALINE CHANNEL SHE ACCIDENTALLY CHOSE THE REMODULIN CHANNEL AND PROGRAMMED A 500CC BOLUS TO BE INFUSED OVER 30 MINUTES. SIX MINUTES LATER, THE PUMP ALARMED WITH AN "AIR IN LINE" ALARM. WHEN THE NURSE WENT BACK INTO THE ROOM, SHE DISCOVERED THAT THE ENTIRE BAG OF REMODULIN (95CC) HAD BEEN INFUSED INTO THE PATIENT AND THE PATIENT WAS NO LONGER RESPONSIVE. SHE ASSESSED THE PATIENT AND DISCOVERED THAT WHILE THE PATIENT HAD A HEART RATE ON THE MONITOR, THE PATIENT HAD NO PULSE OR BLOOD PRESSURE.THE PATIENT HAD CONVERTED INTO A PULSELESS ELECTRICAL ACTIVITY (PEA) ARREST AFTER RECEIVING THE LARGE BOLUS OF REMODULIN. A CODE BLUE WAS CALLED HOWEVER, THE PATIENT COULD NOT BE RESUSCITATED AND ULTIMATELY EXPIRED.WHEN THE RN NOTICED THAT THE PATIENT WAS BOLUSED WITH THE REMODULIN, THE IV PUMP WAS SEQUESTERED AND SENT TO BIOMEDICAL ENGINEERING SO THE DATA LOGS COULD BE REVIEWED.REVIEW OF THESE LOGS REVEALED THAT THE INCORRECT PUMPING CHANNEL WAS INDEED PROGRAMMED TO DELIVER THE FLUID BOLUS. ANALYSIS OF THE LOGS REVEALED THAT THE REMODULIN CHANNEL AND NOT THE NORMAL SALINE CHANNEL WAS PROGRAMMED TO DELIVER THE 500CC FLUID BOLUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PC INFUSION PUMP FRN CAREFUSION CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death OTHER| CARDIAC DRUGS