BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXPLUS TRI-FUSE EXTENSION SET

    MDR report key: 3634199 · Received November 20, 2013

    Report

    Report Number
    9616066-2013-00935
    Event Type
    Malfunction
    Date Received
    November 20, 2013
    Date of Event
    October 14, 2013
    Report Date
    November 7, 2013
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K051499
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER STATED THAT THE PRODUCT WILL NOT BE RETURNED. UNABLE TO DETERMINE THE CAUSE OF THE REPORT THAT THE MIDDLE SECTION OF Y CONNECTOR WAS LEAKING CAUSING BLOOD TO BACK UP INTO THE LINE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE MIDDLE SECTION OF Y CONNECTOR WAS LEAKING; CAUSING BLOOD TO BACK UP INTO THE LINE. THERE WAS NO REPORT OF PATIENT HARM OR MEDICAL INTERVENTION. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT OR EVENT DETAILS WERE PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604329 MAXPLUS TRI-FUSE EXTENSION SET FPA CAREFUSION CORP. ME1224 13035514

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK