BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS

    MDR report key: 2191894 · Received July 22, 2011

    Report

    Report Number
    2191894
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 22, 2011
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    UPON INSPECTION OF INFUSION PUMPS, EIGHT MODULES AND TWO PUMP CONTROL UNITS (PCU) WERE FOUND TO BE DEFECTIVE. THE UNITS WERE PULLED, REPAIRED AND RETURNED TO SERVICE. SEVEN UNITS WITH MINOR CORROSION OF THE DEVICE IUI CONNECTORS (5 MODULES AND TWO PCUS). 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 PUMP FRN CAREFUSION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *