BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PCU

    MDR report key: 5064201 · Received September 2, 2015

    Report

    Report Number
    MW5056042
    Event Type
    Injury
    Date Received
    September 2, 2015
    Date of Event
    August 30, 2015
    Report Date
    September 2, 2015
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SD, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    ALARIS PCU AND LV MODULE WAS USED TO PROGRAM THE INTRALIPID INFUSION FOR A RATE OF 0.6ML/HR TO RUN OVER 20 HOURS FOR A TOTAL OF 11.2 ML TO BE DELIVERED. THE BAG CONTAINED 50ML OF MEDICATION AND 26ML NEEDED TO PRIME THE TUBING. PUMP WAS PROGRAMMED CORRECTLY TO DELIVER 0.6ML/HR BUT 25ML WERE DELIVERED TO THE PATIENT IN APPROX. 17 MINUTES. OVERDELIVERY WAS EVIDENT. PUMP SHOWED THAT ONLY 0.16ML WAS TO BE DELIVERED IN THAT TIME FRAME. ADDITIONAL LABS WERE DRAWN FOR TRIGLYCERIDE LEVELS, INCREASED MONITORING WAS INITIATED. PATIENT MAINTAINED ON ROOM AIR. PUMP, LV MODULE AND TUBING SEQUESTERED AND SENT BACK TO THE COMPANY FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582695 ALARIS PCU PRIMARY TUBING FPA CAREFUSION REF 2426-0007

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA Other