BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS MEDLEY

    MDR report key: 3072600 · Received March 7, 2013

    Report

    Report Number
    3072600
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 25, 2013
    Report Date
    March 7, 2013
    Manufacturer
    CAREFUSION303, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    PT WITH PREEXISTING C4-5 QUADRIPLEGIA HAD UNDERGONE OPERATIVE CYSTECTOMY. AN 18G IV CATHETER WAS PLACED IN THE LEFT EXTERNAL JUGULAR FOR PLANNED BLOOD TRANSFUSION. TWO UNITS OF PRBC'S PLACED ON ALARIS PUMP AND TRANSFUSED AT 500CC/HOUR, FOLLOWED BY 500CC LR BOLUS AT RAPID 999 RATE. SOON AFTER IV INFILTRATION NOTED ON LEFT NECK. THE PUMP WAS STOPPED. THE PUMP NEVER ALARMED WITH OCCLUSION WARNINGS DURING PRBC OR LR TRANSFUSIONS RAPID RATES, WITH CONTINUED INFUSION INTO INFILTRATED TISSUE.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98635 ALARIS MEDLEY PUMP, INFUSION FRN CAREFUSION303, INC. 8000BX03EE *

    Patients

    Seq Age Sex Outcome Treatment
    1 *