BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS 8015

    MDR report key: 2233236 · Received August 22, 2011

    Report

    Report Number
    2233236
    Event Type
    Malfunction
    Date Received
    August 22, 2011
    Date of Event
    August 19, 2011
    Report Date
    August 22, 2011
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    APPROXIMATELY A MONTH AGO, WE RECEIVED 1195 PUMP CONTROL UNITS (PCU), MODEL NUMBER 8015, 1792 IV PUMP MODULES AND 140 PATIENT CONTROLLED ANALGESIA (PCA) MODULES. THESE UNITS ARE TO REPLACE OUR BAXTER COLLEAGUE UNITS PER THE 2010 RECALL AND REPLACEMENT ORDER.APPROXIMATELY TWO WEEKS LATER, ALL PRODUCTS HAD BEEN INCOMING INSPECTED AND DOCUMENTED. DEPLOYMENT WAS SET FOR LATER THIS MONTH.A FEW DAYS AGO, WE RECEIVED A CALL FROM THE MANUFACTURER, CAREFUSION. THEIR QUALITY CONTROL DEPARTMENT HAD IDENTIFIED AN ISSUE WITH NEWLY MANUFACTURED PRODUCTS. A 1182 OF OUR 1195 8015 PCUS WERE AFFECTED BY THE ISSUE. ALL AFFECTED PRODUCT IS TO BE RETURNED TO CAREFUSION AND REPLACEMENT PRODUCT WILL BE SHIPPED. REPLACEMENT PRODUCT HAS NOW BEGUN TO ARRIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS 8015 INFUSION PUMP FRN CAREFUSION ALARIS 8015 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *