BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2221923 · Received August 17, 2011

    Report

    Report Number
    9616066-2011-00463
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 26, 2011
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED AND AN INVESTIGATION IS PENDING. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED BACK FLOW FROM THE SECONDARY (ANTIBIOTIC) INTO THE PRIMARY FLUID. THERE WAS NO PT HARM AND NO MEDICAL INTERVENTION WAS REQUIRED. NO ADDITIONAL EVENT OR PT INFO WAS PROVIDED BY THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP. 2410-0500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK