BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2920200 · Received January 9, 2013

    Report

    Report Number
    9616066-2012-00939
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    December 3, 2012
    Report Date
    December 12, 2012
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT WILL BE RETURNED PER CUSTOMER AS SET WAS DISCARDED. THE CUSTOMER COMPLAINT OF SILICONE SEGMENT BURST AND SPLASHED FLUID COULD NOT BE CONFIRMED DUE TO THE PRODUCT WAS NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED. NOTE: A COPY OF THE DFU INSTRUCTION TO CLAMP TUBING ABOVE THE SMARTSITE VALVE BEFORE ADMINISTERING IV PUSH MEDICATIONS WAS PROVIDED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN IV PUSH MEDICATION FLOWED UP THE TUBING AND BURST THE SILICONE SEGMENT. DETAILS OF THE EVENT WERE REPORTED AS FOLLOWS: A PROPOFOL INFUSION WAS RUNNING VIA GRAVITY AND THE NURSE DID NOT CLAMP THE TUBING ABOVE THE SMARTSITE VALVE BEFORE ADMINISTERING AN IV PUSH OF NORMAL SALINE. THE NURSE FLUSHED THE SECOND SMARTSITE VALVE CLOSEST TO THE PT. THE BURST OCCURRED IN THE MIDDLE OF THE SILICONE SEGMENT AND FLUID SPLASHED INTO THE NURSE'S EYES. THE NURSE IMMEDIATELY FLUSHED HER EYES AND WENT TO URGENT CARE. BLOOD WORK WAS DRAWN AT URGENT CARE. THERE WAS NO OBVIOUS INJURY TO THE NURSE'S EYES AND THE NURSE WAS RELEASED BACK TO WORK FULL DUTY. THE CUSTOMER STATED THAT NO FURTHER PT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12848 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP 2426-0007 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention