BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAREFUSION ALARIS PUMP

    MDR report key: 2994254 · Received February 28, 2013

    Report

    Report Number
    MW5029235
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    February 17, 2013
    Report Date
    February 28, 2013
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT NOTED TO HAVE INCREASED COUGH AND HYPOTENSION. FAMILY IN ROOM AND CALLED NURSE. NURSE NOTED AIR-IN-LINE AND STOPPED INFUSION. DOCTOR CALLED AND PATIENT NOTED TO IMPROVE TO BASELINE. THIS EVENT WAS PRECEDED BY A SIMILAR EVENT ON (B)(6) 2013 ON THE SAME UNIT WHICH MADE THE ORGANIZATION BEGIN A DEEPER INVESTIGATION. WE BEGAN AGGRESSIVE CASE FINDING AND FOUND AN EARLIER INCIDENT WE BELIEVE IS RELATED THAT OCCURRED ON (B)(6) 2013 AND HAS BEEN REPORTED SEPARATELY. DATES OF USE: UNKNOWN TO (B)(6) 2013. DIAGNOSIS: ACUTE LYMPHOBLASTIC LEUKEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87217 CAREFUSION ALARIS PUMP INFUSION PUMP FRN CAREFUSION
    87218 SMARTSITE TUBING IV TUBING FPA CAREFUSION

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention