BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS SYSTEM PUMP MODULE

    MDR report key: 1314074 · Received February 11, 2009

    Report

    Report Number
    2016493-2009-00011
    Event Type
    Injury
    Date Received
    February 11, 2009
    Date of Event
    January 19, 2009
    Report Date
    January 22, 2009
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCTS
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION REQUESTED AND ALL AVAILABLE INFORMATION, AS OF THE DATE OF THIS REPORT IS INCLUDED.

    Description of Event or Problem · 1

    HOSPITAL REPORTED THAT A NEWER NURSE MISPROGRAMMED THE PUMP, WHICH CAUSED AN OVERINFUSION OF AMIODARONE TO A PATIENT. DOCTOR ORDERED A LOADING DOSE OF 150MG/100ML OVER 10 MINUTES (RATE OF 600ML/HR). NURSE REPORTED TO HAVE PROGRAMMED THE VTBI TO 400ML, SO THE PUMP CONTINUED TO INFUSE AT 600ML/HR PAST THE 100ML LOADING DOSE. PATIENT WAS FOUND WITH HEART RATE IN THE 30'S, WAS VENTILATED AND TRANSFERRED TO THE ICU. PLACED ON MULTIPLE DRIPS INCLUDING DOPAMINE AND LEVOPHED. EXTUBATED IN 2009. ALL DIAGNOSTIC TESTING WAS NEGATIVE. PATIENT HAS BEEN DISCHARGED HOME. EVENT LOG REVIEW CONFIRMED WHAT THE HOSPITAL REPORTED. AT 10:19AM, AMIODARONE WAS SELECTED FROM THE DRUG LIBRARY. THERE ARE THEN TWO OPTIONS, LOADING DOSE AND MAINTENANCE DOSE. THE NURSE CHOSE LOADING DOSE. THE OPTIONS ARE THEN FOR 150MG/100ML OR ___MG/___ML. THE NURSE CHOSE 150MG/100ML. THE DRUG CONCENTRATION WAS 1.5MG/ML. THE USER THEN ENTERED A VTBI OF 400ML AND STARTED THE INFUSION. THE PRESET RATE FOR THIS OPTION IS 600ML/HR. AT 10:59AM, THE INFUSION WAS STOPPED AND THE CHANNEL WAS TURNED OFF. VOLUME INFUSED DURING THIS TIME WAS 391.1MLS (586.65MG). HOSPITAL REPORTED THEY WILL REVIEW DATASET, PROCESS AND TRAINING TO PREVENT SIMILAR ERRORS IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SYSTEM PUMP MODULE FRN CARDINAL HEALTH ALARIS PRODUCTS 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening| R PCU