BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXPLUS BI-FUSE EXTENSION SET

    MDR report key: 2221930 · Received August 17, 2011

    Report

    Report Number
    9616066-2011-00457
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 4, 2011
    Report Date
    July 19, 2011
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K051499
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, SET HAS NOT BEEN RECEIVED. A F/U REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE SET BE RECEIVED FOR EVAL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE IV HAD BEEN INFUSING FOR AWHILE BEFORE A LEAK WAS NOTED IN THE EXTENSION SET. THE LEAK IS LOCATED WHERE THE Y JOINS INTO ONE LINE. IT IS UNK AT THIS TIME WHETHER THE SET IS AVAILABLE. THERE WAS NO PT HARM AND NO MEDICAL INTERVENTION WAS REQUIRED. THE CUSTOMER STATED THAT NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXPLUS BI-FUSE EXTENSION SET FPA CAREFUSION CORP. MP9238-C 10043556

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK