BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXPLUS EXTENSION SET

    MDR report key: 2190077 · Received June 29, 2011

    Report

    Report Number
    9616066-2011-00349
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    May 18, 2011
    Report Date
    June 2, 2011
    Manufacturer
    CARE FUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K051499
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UNABLE TO DETERMINE THE CAUSE OF THE CUSTOMER'S REPORTED LEAK. THE ORIGINAL DEVICE WITH THE LEAK HAS BEEN DISCARDED. A FAILURE INVESTIGATION COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT AN EXTENSION SET IS LEAKING WHERE THE MINIBORE TUBING INSERTS INTO THE PLASTIC WINGED GRIPPER. THE CUSTOMER IS CHANGING THE EXTENSION SET ONCE A WEEK. THE EXTENSION SET NEEDED TO BE CHANGED OUT EARLY DUE TO THE LEAK. CUSTOMER STATES NO FURTHER PT OR EVENT INFO IS AVAILABLE. THE LEAKING SET HAS BEEN DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXPLUS EXTENSION SET FPA CARE FUSION CORP MP9014-C UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK