BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALARIS PC UNIT

    MDR report key: 1925501 · Received December 9, 2010

    Report

    Report Number
    2016493-2010-00493
    Event Type
    Other
    Date Received
    December 9, 2010
    Date of Event
    September 23, 2010
    Report Date
    November 16, 2010
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K051641
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT DATE: 12/08/2010. (B)(4). PRODUCT WAS REC'D. THE INVESTIGATION IS NOT COMPLETE. A F/U REPORT WILL BE SUBMITTED WITH ANY RELEVANT INFO.

    Description of Event or Problem · 1

    CUSTOMER REPORTED PC UNIT ALARMED FOR COMMUNICATION ERROR, ALL CHANNELS STOPPED INFUSING AND THE USER WAS UNABLE TO ACCESS ANY CHANNELS. THE PT'S BLOOD PRESSURE DECREASED TO 73/37, THE PUMPS WERE QUICKLY REPLACED AND THE PT'S BLOOD PRESSURE INCREASED ONCE THE DOPAMINE INFUSION WAS RESTARTED. NO ADD'L MEDICAL INTERVENTION WAS REQUIRED. MEDICATIONS INFUSING AT THE TIME OF THE COMMUNICATION ERRORS WERE DOPAMINE 400 MG/250 ML D5W AT 3 MCG/KG/MIN, FENTANYL 1500 MCG/150 ML NS AT 50 MCG/HR AND PROPOFOL 1000 MG/100 ML AT 30 MCG/KG/MIN. NO ADD'L EVENT INFO PROVIDED.

    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 76 YR Other SN (B)(4)| SN (B)(4)| SN (B)(4)| ALARIS PUMP MODULES: SN (B)(4)