BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH / ALARIS PRODUCTS

    MDR report key: 877208 · Received July 9, 2007

    Report

    Report Number
    MW5002986
    Event Type
    Malfunction
    Date Received
    July 9, 2007
    Date of Event
    June 19, 2007
    Report Date
    June 25, 2007
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS PT HAD OPEN HEART SURGERY AT HOSPITAL. HE RETURNED FROM SURGERY & THE PUMP APPEARED TO BE IN RUNNING MODE. THE 20 ML SYRINGE APPEARED TO HAVE MORE THAN 30 ML IN IT. THE SYRINGE BARREL FLANGE WAS NOT SEATED PROPERLY, NOR MADE ANY CONTACT WITH THE FLANGE DETECTOR SWITCH. THE PLUNGE DETECTOR SWITCH WAS ENGAGED. THE GREEN LIGHT WAS "ON" ABOVE THE ML/HR SEGMENTS. THE AMBER LEDS WERE PASSING FROM RIGHT TO LEFT, STATING 5 ML/HR OF CALCIUM CHLORIDE. THE PRESSURE DESK WAS IN PLACE. THE PLUNGER WAS BARELY IN THE SYRINGE BARREL AND AT AN ANGLE. THE PLUNGER WAS ENGAGED WITH THE PLUNGER DETECTOR. THE SYRINGE PUMP WAS LABELED AS DEVICE C. ON THE PC DISPLAY, IT READ 15.9 ML DELIVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDINAL HEALTH / ALARIS PRODUCTS ALARIS SYRINGE PUMP PCU FRN 8000 NA
    2 CARDINAL HEALTH / ALARIS PRODUCTS ALARIS SYRINGE PUMP FRN 8110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO