BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALARIS SIGNATURE EDITION PUMP

    MDR report key: 1760495 · Received July 12, 2010

    Report

    Report Number
    2016493-2010-00452
    Event Type
    Other
    Date Received
    July 12, 2010
    Date of Event
    June 6, 2010
    Report Date
    June 18, 2010
    Manufacturer
    CAREFUSION CORP
    Product Code
    FRN
    PMA / PMN Number
    K931549
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT DATE: 7/14/2010. (B)(4). THE PUMP WAS REC'D, INVESTIGATION IS NOT COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE INVESTIGATION FINDINGS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED PUMP WAS INFUSING ON A PT. NURSE WAS IN THE ROOM AND NOTICED SMOKE AND FLAMES COMING FROM THE BACK OF THE PUMP. NURSE PULLED THE PUMP OFF THE PT AND REMOVED THE PT FROM THE ROOM AND EXTINGUISHED THE FIRE. NO PT/USER HARM. FACILITY BIOMED DISASSEMBLED PARTS AND NOTED THAT THE FIRE WAS MOSTLY CONFINED TO THE FEMALE END OF THE POWER CORD AND SURROUNDING AREA OF THE DEVICE. CAUSE OF THE EVENT WAS NOT DETERMINED BY THE BIOMED. NO ADD'L INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SIGNATURE EDITION PUMP FRN CAREFUSION CORP 7100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK