BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3944152 · Received May 7, 2014

    Report

    Report Number
    9616066-2014-00446
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    March 11, 2014
    Report Date
    April 22, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED LEAKING FROM A HOLE IN THE LOWER HALF OF THE SET DURING AN IV FLUIDS INFUSION. THERE WAS NO PATIENT HARM OR MEDICAL INTERVENTION REQUIRED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274936 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 2123-0007 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK