BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS® PC UNIT

    MDR report key: 5053093 · Received September 3, 2015

    Report

    Report Number
    2016493-2015-00639
    Event Type
    Injury
    Date Received
    September 3, 2015
    Date of Event
    June 4, 2015
    Report Date
    June 8, 2015
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S REPORT WAS CONFIRMED DURING THE SERVICE REPAIR PROCESS; THE PROXIMATE CAUSE OF THE REPORTED ISSUE WAS DETERMINED IN SERVICE TO BE AN ISSUE WITH THE SIO BOARD, WHICH WAS REPLACED. NO FURTHER INVESTIGATION WAS PERFORMED BECAUSE THE DEVICE WAS SENT TO SERVICE BY THE CUSTOMER, AND WAS RETURNED TO THE CUSTOMER PRIOR TO OUR NOTIFICATION OF PATIENT INVOLVEMENT. A FOLLOWUP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED A SYSTEM ERROR 132.3000 AND SENT THE DEVICE THROUGH STANDARD CAREFUSION SERVICE FOR REPAIR, INDICATING THAT THERE WAS NO PATIENT INVOLVEMENT. SUBSEQUENTLY A CUSTOMER MEDWATCH WAS RECEIVED WHICH STATES "PUMP SUDDENLY ALARMED 'SYSTEM ERROR' 'OPERATING CHANNELS WILL CONTINUE AS PROGRAMMED' 'SETTINGS UNRESTORABLE, RECORD BEFORE PRESSING SYSTEM OFF'. THIS IV PUMP WAS THE CARRIER FLUID FOR CONTINUOUS DRIP MEDICATIONS. THE PATIENT RECEIVED A SMALL BOLUS OF MEDICATION, BUT RETURNED TO BASELINE WITHOUT ANY INTERVENTION NEEDED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586560 ALARIS® PC UNIT PUMP, INFUSION FRN CAREFUSION 8015

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO Other PRI TUBING,8100, THERAPY DATE (B)(6) 2015