BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE EXTENSION SET

    MDR report key: 3772348 · Received January 8, 2014

    Report

    Report Number
    9616066-2014-00011
    Event Type
    Malfunction
    Date Received
    January 8, 2014
    Report Date
    December 18, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K960280
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT INFORMATION REQUESTED AND ALL AVAILABLE INFORMATION IS INCLUDED IN SECTIONS A AND B. THIS REPORT WAS FILED BY THE MANUFACTURER. SAMPLE INVOLVED IN THIS EVENT WILL NOT BE RETURNED. NO FAILURE INVESTIGATION COULD BE PERFORMED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A BLOOD TRANSFUSION THEY OBSERVED "A CRACK AT THE DISTAL END OF THE EXTENSION SET (WHERE THE ALARIS SYSTEM LINE WAS CONNECTED)." AS THIS WAS PROMPTLY DISCOVERED, THERE WAS MINIMAL BLOOD LOSS FROM THE SET. FROM THE REPORTED INFORMATION, THERE ARE NO INDICATIONS OF SERIOUS INJURY TO THE PATIENT OR USER AS A RESULT OF THIS INCIDENT. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14859 SMARTSITE EXTENSION SET FPA CAREFUSION CORPORATION 30202E 13086289

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK