BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE SET

    MDR report key: 4131319 · Received September 19, 2014

    Report

    Report Number
    4131319
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    May 3, 2014
    Report Date
    September 19, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    AT BEDSIDE I SMELLED TPN AND LOOKED AROUND AND DID NOT SEE A LEAK ANYWHERE; AFTER ABOUT AN HOUR I LOOKED AGAIN AND CONTINUED TO SMELL IT THEN I LOOKED ON THE BED AND THERE WAS A WET SPOT AND SOME ON THE FLOOR. UPON INVESTIGATION, LEAK FOUND IN TUBING APPROX 2-3 INCHES FROM LUER CONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583545 ALARIS PUMP MODULE SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR NOT APPLICABLE.