BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS INFUSION PUMP

    MDR report key: 1201808 · Received October 15, 2008

    Report

    Report Number
    2016493-2008-00151
    Event Type
    Injury
    Date Received
    October 15, 2008
    Report Date
    September 22, 2008
    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
    NM, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    CUSTOMER SENT EMAIL REPORT OF FENTANYL OVER INFUSION ON SE PUMP. EMAIL STATED RATE OF 44.5ML/HR WAS SUPPOSED TO BE 4.5ML/HR. THE PATIENT HAD RECEIVED A 10 FOLD OVERDOSE FOR SEVERAL HOURS. THIS DELAYED WEANING FROM THE VENTILATOR BECAUSE HE WAS NOT BREATHING ON HIS OWN. THE PATIENT WAS WEANED FROM THE VENTILATOR SHORTLY AFTER THE DOSE WAS CORRECTED. CUSTOMER STATED WAS ABLE TO REPRODUCE KEY BOUNCE WITH THE DEVICE. CUSTOMER WAS CONTACTED, AND STATED IT HAD OCCURRED BEFORE THE SE RECALL SOMETIME IN REMOTE PAST. DEVICE AND SPECIFICS OF EVENT ARE NO LONGER AVAILABLE, AND CUSTOMER HAS NO FURTHER INFORMATION, DETAILS, OR SERIAL NUMBER. A CARDINAL HEALTH RECORD SEARCH SHOWED NO PREVIOUS COMPLAINTS REPORTED FOR THIS EVENT FOR THIS CUSTOMER. FOUR ADDITIONAL EMAIL AND TELEPHONE ATTEMPTS FOR INFORMATION UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS INFUSION PUMP FRN INFUSION PUMP FRN CARDINAL HEALTH ALARIS PRODUCTS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention