BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 4799091 · Received May 27, 2015

    Report

    Report Number
    2016493-2015-00383
    Event Type
    Death
    Date Received
    May 27, 2015
    Date of Event
    May 3, 2015
    Report Date
    May 4, 2015
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REQUESTS EVENT LOG REVIEW. THE EVENT LOGS HAVE BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH EVALUATION RESULTS AFTER THE COMPLETION OF THE EVENT LOG REVIEW. NO DEVICES RECEIVED, LOG REVIEW ONLY.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT OF AN OVER INFUSION OF MIDAZOLAM WAS CONFIRMED. THE ASSOCIATED PCU LOGS WERE REVIEWED AND SHOWED MIDAZOLAM WAS PROGRAMMED TO INFUSE AT 3 MG/KG/H. DURING PROGRAMMING, A GUARDRAILS ALERT OCCURRED BECAUSE THE DOSE WAS ABOVE THE SOFT GUARDRAILS LIMIT OF 0.1MG/KG/H. THE USER SELECTED "YES" TO PROCEED, AND THE INFUSION WAS STARTED AT 180ML/HR. THE INFUSION RAN FOR APPROXIMATELY 17 MINUTES. THE USER CHANGED THE DOSE TO 2MG/KG/H, RECEIVED ANOTHER SOFT GUARDRAILS ALERT, AND STARTED THE INFUSION AT 120ML/HR. THE INFUSION RAN FOR 21 MINUTES UNTIL THE USER REPROGRAMMED THE INFUSION AT A DOSE OF 0.02MG/KG/H (RATE OF 1.2ML/HR). THE INFUSION RAN FOR APPROXIMATELY 2 HOURS AND 6 MINUTES AND THEN THE PUMP MODULE WAS POWERED OFF BY THE USER. THE ROOT CAUSE OF THE REPORTED OVER INFUSION OF MIDAZOLAM WAS USER PROGRAMMING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE PATIENT WAS ADMITTED TO THE ED WITH A BLOOD PRESSURE OF 25 MMHG, WAS IMMEDIATELY INTUBATED AND LEVOPHED AND MIDAZOLAM WERE STARTED. THE NURSE PROGRAMMED MIDAZOLAM TO INFUSE AT 2 MG/KG INSTEAD OF THE INTENDED 0.2 MG/KG. THE USER STATED THE DEVICE DID NOT ALARM AND ALLOWED THE 2 MG/KG PROGRAMMING. TWO HOURS AFTER THE START OF THE MIDAZOLAM, THE PATIENT "CODED" AND DIED. THE CUSTOMER DOES NOT ALLEGE OR ATTRIBUTE THE MIDAZOLAM PROGRAMMING OR ANY DEVICE MALFUNCTION TO THE PATIENT¿S DEMISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344150 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 Death 8015,(2)8100, PRI TUBING