BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXPLUS EXTENSION SET

    MDR report key: 2190076 · Received June 29, 2011

    Report

    Report Number
    9616066-2011-00350
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    February 11, 2011
    Report Date
    June 2, 2011
    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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UNABLE TO DETERMINE THE CAUSE OF THE CUSTOMER'S REPORTED LEAK. THE CUSTOMER STATED THE DISPOSABLE HAS BEEN DISCARDED AND FAILURE INVESTIGATION COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT AN EXTENSION SET WAS IN FOR A FEW DAYS AND WHEN THE SET WAS BEING FLUSHED WITH SALINE, THE SET BURST AND LEAKED. THE SET HAS BEEN DISCARDED AND WILL NOT BE RETURNED. NO PT HARM OR MEDICAL INTERVENTION REQUIRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK