BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2101936 · Received May 17, 2011

    Report

    Report Number
    9616066-2011-00257
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 21, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K894842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: 05/17/2011. (B)(4). DEVICE HAS BEEN RECEIVED. INVESTIGATION IS NOT COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE INVESTIGATION FINDINGS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED WHEN THE NURSE WAS SETTING UP THE LINE PRIOR TO PT USE, IT FELL APART. ALTHOUGH REQUESTED, NO ADDITIONAL INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 2477-0000 11015583

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK