BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PC UNIT

    MDR report key: 1781041 · Received July 28, 2010

    Report

    Report Number
    2016493-2010-00456
    Event Type
    Injury
    Date Received
    July 28, 2010
    Date of Event
    June 8, 2010
    Report Date
    July 2, 2010
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FRN
    PMA / PMN Number
    K051641
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT DATE: 7/28/2010. (B)(4). THE DEVICE HAS BEEN REQUESTED TO BE RETURNED FOR INVESTIGATION, IT HAS NOT BEEN SENT BY THE FACILITY REPORTER. A FOLLOW UP REPORT WILL BE SUBMITTED IF FURTHER INFO IS OBTAINED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED "ALARIS PUMP RUNNING A FLOLAN DRIP. THE PUMP TURNED RED AND READ 'MALFUNCTION' AND THEN TURNED OFF. PT WAS OFF OF FLOLAN FOR A FEW MINUTES WHILE BACKUP PUMP AT BEDSIDE WAS BEING PREPPED FOR SWITCH. PT EXPERIENCED SIDE EFFECTS DUE TO THIS PUMP MALFUNCTION - LOW BLOOD PRESSURE/OXYGEN DESATURATION TO THE LOW 80'S. RAPID RESPONSE TEAM ACTIVATED AND PT RETURNED TO BASELINE AFTER 30 MINUTES." ALTHOUGH REQUESTED, NO ADDITIONAL INFO HAS BEEN PROVIDED.

    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 UNK Other ALARIS PUMP MODULE, SERIAL # UNK