BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PC UNIT

    MDR report key: 1730512 · Received June 16, 2010

    Report

    Report Number
    2016493-2010-00443
    Event Type
    Injury
    Date Received
    June 16, 2010
    Report Date
    May 17, 2010
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K051641
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS FILED BY THE MANUFACTURER. PC UNIT EVENT LOGS HAVE BEEN RECEIVED FOR INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE INVESTIGATION FINDINGS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ALARIS SYSTEM WITH 4 CHANNELS INFUSING VASOPRESSIN 0.04 UNITS/MIN, LEVOPHED 20MG/MIN, NEOSYNEPHRINE 225MCG/MIN AND AMIODARONE 0.5MG/MIN ALARMED FOR COMMUNICATION ERROR. THE PT EXPERIENCED A DROP IN BLOOD PRESSURE, THE SYSTEM WAS SWITCHED TO 4 ADDITIONAL PUMPS AND THE DRIPS WERE INCREASED TEMPORARILY FOR APPROXIMATELY 7 MINUTES UNTIL THE PT'S BLOOD PRESSURE RECOVERED. THE PT WAS IN CARDIOGENIC SHOCK ON MAXIMUM PRESSURES AND INTRA-AORTIC BALLOON PUMP FULL SUPPORT. NO FURTHER PT/EVENT INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PC UNIT FRN CAREFUSION CORPORATION 8015 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention FOUR ALARIS PUMP MODULES, SERIAL # UNK