BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS INFUSION SYSTEM

    MDR report key: 1231844 · Received November 12, 2008

    Report

    Report Number
    2016493-2008-00175
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    October 12, 2008
    Report Date
    October 22, 2008
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCTS
    Product Code
    FRN
    PMA / PMN Number
    K02364
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT DATE: 11/12/2008. A REVIEW OF THE DEVICE EVENT LOG FOUND THAT THE INITIAL DOSE OF 0.1 MCG/KG/MIN (0.12 ML/HR) AND THE HIGH DOSE OF 0.728 MCG/KG/MIN (0.9 ML/HR) ARE BOTH WITHIN THE GUARDRAIL LIMITS. THE LOG REVIEW CONFIRMED THAT THE INFUSION WAS RUNNING AT A RATE OF 0.12 ML/HR FOR AN EXTENDED PERIOD OF TIME UP UNTIL 8:29 AM ON THE DAY OF THE INCIDENT. AT THAT TIME THE MODULE WAS ACCESSED AND THE RATE WAS CHANGED TO 0.9 ML/HR (0.728 MCG/KG/MIN). THE REPORTED OVER INFUSION EVENT WAS DUE TO USER PROGRAMMING. RECOMMENDED CUSTOMER PERFORM A DATA SET REVIEW TO DETERMINE IF THE GUARDRAIL LIMITS SURROUNDING THE DRUG IN QUESTION IS ADEQUATE. PT INFO REQUESTED AND ALL AVAILABLE INFO IS INCLUDED. THIS REPORT WAS FILED BY THE MFR.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN OVER INFUSION OF EPINEPHRINE OCCURRED AND REQUESTED AN EVENT LOG REVIEW TO CHECK PROGRAMMING. EPINEPHRINE CONCENTRATION 50MCG/ML WAS INFUSING AT 0.12ML/HR. A NURSE PRACTIONER WROTE AN ORDER TO DECREASE THE EPINEPHRINE TO 0.9ML/HR, WHICH IS ACTUALLY A HIGHER DOSE THAN WHAT WAS INFUSING. NURSE REPORTED SHE WAS AWARE OF THE INCORRECT ORDER AND SAID SHE PROGRAMMED FOR 0.09ML/HR INSTEAD OF THE 0.9ML/HR THAT WAS ORDERED. BABY IS NOW SUFFERING FROM NECROSIS OF THE FINGERS WITH THE POSSIBILITY OF AMPUTATION IF THE BABY SURVIVES. THE CUSTOMER'S DATA SET WAS REVIEWED FOR EPINEPHRINE IN THE NEONATAL PROFILE. THE SOFT GUARDRAIL MINIMUM OF 0.05 MCG/KG/MIN AND SOFT GUARDRAIL MAXIMUM OF 2 MCG/KM/MIN WERE IDENTIFIED. NO HARD GUARDRAIL LIMITS WERE SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS INFUSION SYSTEM FRN, INFUSION SYSTEM FRN CARDINAL HEALTH ALARIS PRODUCTS 8110 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention ALARIS PC UNIT