BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PC UNIT

    MDR report key: 2140732 · Received June 15, 2011

    Report

    Report Number
    2016493-2011-00369
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 18, 2011
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FRN
    PMA / PMN Number
    K051641
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES HAVE BEEN REC'D, BUT THE INVESTIGATION HAS NOT YET BEGUN. A F/U REPORT WILL BE SUBMITTED ONCE THE DEVICES HAVE BEEN EVALUATED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS A PT WAS GETTING AN INOTROPIC INFUSION AFTER A CARDIAC SURGERY USING ALARIS PUMP. AFTER TWO HOURS OF NORMAL OPERATION, THE PUMP SUDDENLY STOPPED FUNCTIONING AND A "COMMUNICATION ERROR" MESSAGE WAS DISPLAYED. THE PUMP WAS RESET BUT THIS HAPPENED AGAIN AFTER 5 MINUTES OF OPERATION. THE EVENT DID NOT REACH THE PT BECAUSE OF ACTIVE RECOVERY EFFORTS BY CAREGIVERS. THE PUMP WAS TAKEN OUT OF SVC.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR ALARIS PUMP MODULE: (B)(4)| ALARIS PUMP MODULE: (B)(4)| ALARIS PUMP MODULE: (B)(4)| ALARIS PUMP MODULE: (B)(4)| ALARIS PUMP MODULE: (B)(4)