BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 1923317 · Received November 19, 2010

    Report

    Report Number
    9616066-2010-00333
    Event Type
    Malfunction
    Date Received
    November 19, 2010
    Date of Event
    October 21, 2010
    Report Date
    November 3, 2010
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: 11/19/2010. (B)(4). THE SET WAS DISCARDED BY THE FACILITY, THEREFORE, NO FAILURE INVESTIGATION COULD BE DONE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED CHEMOTHERAPY SPIKED TO SMARTSITE BURETTE SET PRIMED WITH NORMAL SALINE. WHEN TUBING LOADED INTO THE PUMP, PUMP BEGAN ALARMING THAT THERE WAS AIR IN LINE. WHEN THE NURSE INVESTIGATED FOR PROBLEMS AND OPENED THE PUMP, SHE NOTED A DISCONNECT IN THE UPPER LINE AT WHAT WAS SUPPOSED TO BE A PERMANENT CONNECTION. NO PATIENT HARM REPORTED. EVENT OCCURRED ON HEM/ONC UNIT. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 2440-0600 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR ALARIS PUMP MODULE: SERIAL NUMBER UNKNOWN