BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXPLUS EXTENSION SET

    MDR report key: 2253015 · Received August 31, 2011

    Report

    Report Number
    9616066-2011-00530
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Date of Event
    August 17, 2011
    Report Date
    August 18, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K083472
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO FAILURE INVESTIGATION COULD BE PERFORMED. THE CUSTOMER INDICATED THE SET WAS DISCARDED. ROOT CAUSE OF THE CUSTOMER'S REPORTED LEAK IS UNK.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A DISCONNECTION AND LEAK OCCURRED AT THE CONNECTION OF THE MALE LUER ON THE EXTENSION SET TO THE FEMALE LUER OF THE IV CATHETER. THE USER NOTED IV FLUID LEAKING SLOWLY FROM THE CONNECTION AND BECAUSE OF THE SLOW INFUSION RATE, NO LEAKING OF BLOOD WAS NOTED. CUSTOMER STATED THAT THEY HAVE MANY NEW STAFF NURSES AND THE ISSUE MAY BE ATTRIBUTED TO INSECURE CONNECTIONS. THERE WAS NO PT HARM REPORTED AND NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXPLUS EXTENSION SET FPA CAREFUSION CORPORATION MP5303-C 11038024

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN