BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3131554 · Received May 16, 2013

    Report

    Report Number
    2016493-2013-00230
    Event Type
    Malfunction
    Date Received
    May 16, 2013
    Date of Event
    April 13, 2013
    Report Date
    April 19, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER'S REPORT OF AN OVER-INFUSION OF PRECEDEX WAS CONFIRMED. THE CAUSE OF THE OVER-INFUSION WAS USER PROGRAMMING. AT 5:22 PM, THE PUMP MODULE WAS PROGRAMMED THROUGH GUARDRAILS TO RUN AN INFUSION OF DEXMEDETOMIDINE 200MCG IN 100ML AT A RATE OF 41.5ML/HR. THE USER ENTERED 90ML FOR THE VTBI, WHICH AT RATE OF 41.5ML/HR WOULD BE EXPECTED TO RUN FOR JUST OVER 2 HOURS. JUST BEFORE STARTING THE INFUSION, THE USER PROGRAMMED A 1MCG/KG BOLUS DOSE TO INFUSE OVER 10 MINUTES. THE RATE FOR THIS BOLUS DOSE WAS 498ML/HR WITH A VTBI OF 83ML. THE BOLUS DOSE RAN FOR APPROXIMATELY 9 MINUTES BEFORE THE USER STOPPED THE BOLUS INFUSION AND STARTED THE PRIMARY INFUSION. THE DEVICE RECORDED 73.565ML OF FLUID DELIVERED DURING THIS TIME. THE USER CLEARED THE VOLUME INFUSED AT 5:54 PM, AFTER RECORDING 341.925ML WAS INFUSED AND THE PRIMARY INFUSION COMPLETED AT 5:55 PM. THE INFUSION LASTED APPROXIMATELY 33 MINUTES AND 90.006ML WAS RECORDED AS DELIVERED. AT 5:57 PM, THE USER CHANGED THE VTBI OF THE PRIMARY INFUSION TO 95 ML AND STARTED THE INFUSION. THE USER AGAIN PROGRAMMED THE 1MCG/KG BOLUS DOSE TO INFUSE OVER TEN MINUTES. THE BOLUS DOSE COMPLETED AT 6:11 PM AND THE DEVICE TRANSITIONS TO THE PRIMARY INFUSION. THE PRIMARY INFUSION COMPLETED AT 6:24 PM, WITH 95.697ML RECORDED AS DELIVERED. THE PCU EVENT LOG SHOWED THAT THERE WERE TWO INFUSIONS OF PRECEDEX (ONE AT 5:22 PM AND ONE AT 5:57 PM) THAT WOULD HAVE INFUSED JUST OVER TWO HOURS ON (B)(6) 2013; HOWEVER EACH INFUSION WAS PROGRAMMED FOR A BOLUS DOSE THAT RAN AT 498ML/HR WITH A VTBI OF 83ML. BECAUSE OF THE BOLUS DOSE, EACH INFUSION RAN FOR APPROXIMATELY 30 MINUTES, INSTEAD OF THE TWO HOURS THAT WAS EXPECTED. THE ROOT CAUSE OF THE REPORTED OVER-INFUSION OF PRECEDEX USER PROGRAMMING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN INFUSION OF PRECEDEX INFUSED FASTER THAN EXPECTED. THE INFUSION WAS TO LAST 2 HOURS BUT THE TOTAL VOLUME INFUSED IN 30 MINUTES. EVENT OCCURRED IN THE ICU. UNKNOWN IF INFUSION WAS HUNG AS A SECONDARY OR PRIMARY, VTBI, INTENDED RATE AND PT'S RESPONSE TO THE OVER INFUSION. CLINICAL CONTACT AND EVENT LOGS HAVE BEEN REQUESTED. THERE WAS NO PT HARM REPORTED AND NO REPORT OF MEDICAL INTERVENTION REQUIRED. ALTHOUGH REQUESTED NO ADDITIONAL PT OR EVENT DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218182 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PUMP MODULE: SN (B)(4)| ALARIS PC UNIT: SN (B)(4)| 2 ALARIS PUMP MODULE ADMIN SETS, MODEL/LOT UNK