BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SE ADMINISTRATION SET

    MDR report key: 3944196 · Received May 7, 2014

    Report

    Report Number
    9616066-2014-00468
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    March 30, 2014
    Report Date
    April 22, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K931550
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE RUBBER BUNG FROM THE INJECTION PORT HAD BECOME DETACHED FROM THE ALARIS SE PRIMARY SET AND WAS FOUND IN THE PATIENT'S MOUTH. THE CENTRAL LINE HAD BLEED A SMALL AMOUNT BACK INTO THE LINE AND THE PARENTERAL NUTRITION HAD TO BE DISCONTINUED AND REPLACED WITH INTRAVENOUS FLUID. THE PATIENT WAS MADE SAFE AND THE CENTRAL LINE WAS CLAMPED TO PREVENT FURTHER BLEEDING. 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
    274913 ALARIS SE ADMINISTRATION SET FPA CAREFUSION CORPORATION 72313-0006 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK CENTRAL LINE, MANUFACTURER/MODEL/LOT: UNK