BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDFUSION 3500 SYRINGE INFUSION PUMP

    MDR report key: 1831755 · Received September 7, 2010

    Report

    Report Number
    2183502-2010-00383
    Event Type
    Death
    Date Received
    September 7, 2010
    Date of Event
    July 17, 2010
    Report Date
    August 31, 2010
    Manufacturer
    SMITHS MEDICAL MD
    Product Code
    FRN
    PMA / PMN Number
    K040899
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE IS CURRENTLY BEING EVALUATED; THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION ONCE IT IS COMPLETED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED STATED THAT TWO (2) DEVICES WERE IN USE WITH A 25 WEEK PRETERM INFANT BEING TREATED FOR SEVERE PREMATURITY, NEONATAL RESPIRATORY DISTRESS SYNDROME, AND SEPSIS. THE DEVICES IN QUESTION WERE BEING USED TO DELIVER DOPAMINE AND DOBUTAMINE RESPECTIVELY. THE DOPAMINE SYRINGE WAS CHANGED AT APPROXIMATELY 21:02, AND THE PATIENT WAS NOTED TO HAVE DECREASED HEART RATE AT APPROXIMATELY 21:04. THE DEVICE ALARMED "SYRINGE NEAR EMPTY" AND THEN "SYRINGE EMPTY" AT 21:23 WHEN IT WAS DISCOVERED THE SYRINGE WAS EMPTY. DURING THIS TIME, RESUSCITATION EFFORTS WERE MADE. THE PATIENT EXPIRED AT 21:30. THIS REPORT IS FOR DEVICE (B)(4) WHICH WAS INFUSING DOPAMINE. TWO INFUSION DEVICES WERE IN USE AT THE TIME OF THE EVENT. ALSO SEE REPORT 2183502-2010-00382 FOR THE OTHER DEVICE IN USE AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDFUSION 3500 SYRINGE INFUSION PUMP SYRINGE INFUSION PUMP FRN SMITHS MEDICAL MD 3500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA Death