BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SE ADMINISTRATION SET

    MDR report key: 2140714 · Received June 15, 2011

    Report

    Report Number
    9616066-2011-00312
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Report Date
    May 20, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K931550
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE INVOLVED IN THIS EVENT WILL NOT BE RETURNED AS IT WAS DISCARDED. NO FAILURE INVESTIGATION COULD BE PERFORMED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT 30 MINUTES INTO A TPN INFUSION, THEY NOTICED A LEAK FROM THE HYDROPHOBIC AIR INLET FILTER. FROM THE REPORTED INFORMATION, THERE ARE NO INDICATIONS OF SERIOUS INJURY TO THE PATIENT OR USER AS A RESULT OF THIS INCIDENT. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SE ADMINISTRATION SET FPA CAREFUSION CORPORATION 72303 10045585

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK