BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2841298 · Received October 26, 2012

    Report

    Report Number
    1314492-2012-00371
    Event Type
    Injury
    Date Received
    October 26, 2012
    Date of Event
    August 7, 2012
    Report Date
    September 26, 2012
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO SIGMA FOR EVAL AND THEREFORE AN EVAL COULD NOT BE COMPLETED. IF THE DEVICE IS RETURNED, AN EVAL WILL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED. SIGMA'S COMPLAINT EVAL WAS UNABLE TO OBTAIN ADD'L INFO AND THE REPORTED INFUSION SET UP IS UNCLEAR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INSULIN AND PROPOFOL INFUSION WAS PROGRAMMED. THE INSULIN WAS ATTACHED TO THE IV ACCESS AND THE PROPOFOL WAS ATTACHED TO THE Y PORT OF THE INSULIN. THE CUSTOMER STATED THAT THE PT'S BLOOD SUGARS CONTINUED TO RISE, DESPITE INCREASING THE INSULIN DRIP. THE NURSE VERIFIED THAT ALL CLAMPS WERE OPEN AND THE PUMP WAS SET TO RUN. IT WAS OBSERVED THAT THE PROPOFOL WAS TRAVELING UP THE INSULIN IV LINE. THE CUSTOMER ALSO STATED THAT "INSULIN DRIP STOPPED IMMEDIATELY, AND MOVED TO A DIFFERENT PUMP AT THE SAME RATE WITH NO CHANGE IN SET UP AND THIS TIME THE INSULIN INFUSED CORRECTLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1