BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAREFUSION ALARIS PUMP

    MDR report key: 2994270 · Received February 28, 2013

    Report

    Report Number
    MW5029232
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    January 18, 2013
    Report Date
    February 28, 2013
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    EVENT DISCOVERED RECENTLY WHILE CASE FINDINGS FOR CURRENT AIR-IN-LINE ISSUES WITH INFUSIONS USING THE ALARIS PUMP AND CAREFUSION SMARTSITE TUBING. PATIENT NOTED TO BE FINE AT CHANGE OF SHIFT (1900). AT 2000 NURSE NOTED PATIENT HAD INCREASED COUGH AND SOB. A RAPID RESPONSE WAS CALLED. NURSE NOTED AIR-IN-LINE AND STOPPED INFUSION. PATIENT GIVEN A FLUID BOLUS AND RETURNED TO BASELINE. PATIENT HAS ACUTE LYMPHOCYTIC LEUKEMIA. DATES OF USE: UNKNOWN TO (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87232 CAREFUSION ALARIS PUMP INFUSION PUMP FPA CAREFUSION
    87233 SMARTSITE TUBING IV TUBING FPA CAREFUSION

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention