BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS

    MDR report key: 2948895 · Received January 31, 2013

    Report

    Report Number
    MW5028850
    Event Type
    Injury
    Date Received
    January 31, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 31, 2013
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS ORDERED INSULIN DRIP. NURSING TIMES 2 RN'S CONFIRMED ORDER AND PROGRAMMED PUMP. PUMP MALFUNCTIONED RESULTING IN 100ML'S OF INSULIN TO BE INFUSED OVER 2 HRS. THE INVOLVED IV PUMP WAS NOTED AS AN ALARIS MODEL # 8015 SERIAL NUMBER (B)(4). DATES OF USE: (B)(6) 2013, LESS THAN 12 HRS. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42575 ALARIS ALARIS FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization