BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS

    MDR report key: 2191897 · Received July 22, 2011

    Report

    Report Number
    2191897
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 22, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    A 35 INFUSION PUMPS WERE INSPECTED IN FOUR DIFFERENT AREAS. FIVE DEFECTIVE MODULES AND ONE PUMP CONTROL UNIT WERE DEFECTIVE. THE UNITS WERE PULLED, REPAIRED AND RETURNED TO SERVICE. EIGHT UNITS WITH MINOR CORROSION (6 MODULES AND 2 PCUS) WERE FOUND. THE CORROSION WAS REMOVED AND THE UNITS PLACED BACK INTO SERVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *