BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS SE PUMP

    MDR report key: 2212928 · Received August 3, 2011

    Report

    Report Number
    2016493-2011-00457
    Event Type
    Injury
    Date Received
    August 3, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 15, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K931549
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT DATE: (B)(4) 2011. (B)(4). THE DEVICE HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A F/U REPORT WILL BE SUBMITTED WITH THE FAILURE INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED SPARKING WHILE PLUGGING THE PUMP INTO THE AC OUTLET ON THE BARIATRIC UNIT. BIOMED INDICATED THAT THERE IS A BURNT PRONG ON THE PLUG. THERE WAS NO PT OR STAFF HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SE PUMP FRN CAREFUSION CORPORATION 7100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other