BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 1984540 · Received February 2, 2011

    Report

    Report Number
    2016493-2011-00213
    Event Type
    Injury
    Date Received
    February 2, 2011
    Date of Event
    December 30, 2010
    Report Date
    January 4, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: 02/02/2011. (B)(4). PCU LOGS AND CUSTOMER DATASET HAVE BEEN RECEIVED, INVESTIGATION IS IN-PROGRESS BUT IS NOT COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    PRECEDEX RUNNING AT 0.1 MCG/KG/HR. 30 MINUTES LATER, THE RATE WAS INCREASED TO 02.2 MCG/KG/HR. TWO HOURS AFTER, THE RATE INCREASE THE BAG OF PRECEDEX WAS EMPTY. THE SETUP WAS VERIFIED BY 2 NURSES. THE PATIENT'S BLOOD PRESSURE DROPPED BRIEFLY BUT REQUIRED NO MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other ALARIS PCUNIT, S/N (B)(4)