BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SE PUMP ADMINISTRATION SET

    MDR report key: 1813164 · Received August 18, 2010

    Report

    Report Number
    9616066-2010-00206
    Event Type
    Malfunction
    Date Received
    August 18, 2010
    Date of Event
    July 6, 2010
    Report Date
    July 22, 2010
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K931550
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE INVOLVED IN THIS EVENT WAS NOT RETURNED. NO FAILURE INVESTIGATION COULD BE PERFORMED. A LOT HISTORY REVIEW WAS DONE AND NO QUALITY ISSUES WERE IDENTIFIED DURING PRODUCTION BUILD.

    Description of Event or Problem · 1

    THE USER REPORTED THAT THEY NOTICED A LEAK THROUGH THE SMARTSITE VALVE DURING A BLOOD TRANSFUSION. FROM THE REPORTED INFORMATION, THERE ARE NO INDICATIONS OF SERIOUS INJURY TO THE PATIENT OR USER AS A RESULT OF THIS INCIDENT. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SE PUMP ADMINISTRATION SET FPA CAREFUSION CORPORATION 72023E 10016111

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK