BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS 8100 PUMP

    MDR report key: 3983582 · Received August 1, 2014

    Report

    Report Number
    MW5037626
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    July 29, 2014
    Report Date
    July 30, 2014
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT ON PRIMACOR IV DRIP VIA CAREFUSION PUMP AT 0.25MCG/KG/MIM, 7 CC/HR. NEW BAG HUNG: AT 0245 PUMP ALARMED THAT FLUID SIDE WAS EMPTY, PUMP SCREEN INDICATED THAT VOL TO BE INFUSED WAS 49.5 CC, HOWEVER, IV BAG WAS EMPTY. VERIFIED WITH PHARMACY THAT BAG WAS 100CC, AFTER LOOKING BACK AT THE HISTORY THE FIRST BAG INFUSED IN 8 HR 15 MINUTES AND THE SECOND ONE 7 HR 13 MINUTES, WHEN IT SHOULD HAVE TAKEN 13.9 HOURS TO INFUSE. NO ADVERSE PT EVENT - PUMP REMOVED FROM SERVICE. BIOMED AT THIS FACILITY STATED THAT A SENSOR ON THE PUMP IS BAD AND PUMP WAS SENT TO MANUFACTURER FOR REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451600 ALARIS 8100 PUMP NONE FRN CAREFUSION

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention