BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALARIS INFUSION SYSTEM

    MDR report key: 1242512 · Received November 21, 2008

    Report

    Report Number
    2016493-2008-00201
    Event Type
    Other
    Date Received
    November 21, 2008
    Date of Event
    April 25, 2008
    Report Date
    May 8, 2008
    Manufacturer
    CARDINAL HEALTH ALARIS RPODUCTS
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S INFORMATION REQUESTED, AND ALL AVAILABLE INFORMATION IS INCLUDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED FENTANYL DRIP PROGRAMMED WITH A RATE OF 5ML AND SPONTANEOUSLY INCREASED TO A RATE OF 25ML. THE REPORTED COMPLAINT OF A SPONTANEOUS RATE CHANGE COULD NOT BE VERIFIED. REVIEW OF THE DEVICE EVENT LOG FOR THE TIME PERIOD OF THE COMPLAINT SHOWED THAT THE DEVICE WAS INITIALLY PROGRAMMED WITH A RATE OF 25ML/HR IN THE LATE EVENING. IN THE MORNING OF THE NEXT DAY, THE DEVICE'S RATE WAS CHANGED TO 5ML/HR. THE RATE WAS CHANGED TO 43ML/HR APPROXIMATELY 3.5 HOURS LATER WITH THE DEVICE COMPLETING THE PROGRAMMED INFUSION AT THIS RATE. NO SPONTANEOUS RATE CHANGES WERE DETECTED. THE DEVICE INFUSED APPROPRIATELY AT THE RATES ENTERED. DEVICE INSPECTION DETERMINED NO ISSUES OR ANOMALIES AND TESTING OF THE DEVICE DETERMINED THE DEVICE IS OPERATING WITHIN SPECIFICATIONS. THE ROOT CAUSE FOR THE REPORTED COMPLAINT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS INFUSION SYSTEM FRN, INFUSION SYSTEM FRN CARDINAL HEALTH ALARIS RPODUCTS 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other