BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA SMART PUMP

    MDR report key: 1638203 · Received March 18, 2010

    Report

    Report Number
    MW5015226
    Event Type
    Injury
    Date Received
    March 18, 2010
    Date of Event
    March 2, 2010
    Report Date
    March 18, 2010
    Manufacturer
    SIGMA
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    VANCOMYCIN DOSE AS A SECONDARY INFUSION WAS PROGRAMMED INTO A FENTANYL INFUSION -SET UP AS A PRIMARY-. THIS INCREASED THE RATE OF THE FENTANYL INFUSION TO 167 ML/HR. THE SIGMA ALARMED AS THE FENTANYL BAG WAS EMPTY. THEN 19 ML OF FENTANYL HAD BEEN ADMINISTERED AT A RATE OF 167 ML/HR. THIS CAN OCCUR DUE TO THE FOLLOWING FUNCTIONALITY WITHIN THE SIGMA DEVICE: AT PRESENT THE DESIGNATION PRIMARY ONLY, MEANS THAT THE PROGRAMMER IS NOT ABLE TO PROGRAM AN INFUSION THAT SHOULD ONLY BE RUN AS A PRIMARY AS A SECONDARY INFUSION. IT DOES NOT PREVENT THE PROGRAMMING OF A SECONDARY INFUSION INTO AN INFUSION THAT SHOULD NOT ALLOW FOR SECONDARY INFUSIONS -IE A PROGRAMMER CAN PROGRAM AN INTERMITTENT ANTIBIOTIC OR ELECTROLYTE REPLACEMENT INTO A PRIMARY INFUSION SUCH AS PROPOFOL WHICH MAY BE EITHER INCOMPATIBLE OR INCREASE THE RATE OF THE SECONDARY INFUSION WHICH MAY LEAD TO SIGNIFICANT OVERDOSAGE-. IT IS OUR UNDERSTANDING THAT THE FIX FOR PROBLEM IS TO BE INCLUDED IN THE NEXT SOFTWARE RELEASE -RECENTLY PULLED FROM (B) (6). EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? - YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA SMART PUMP SIGMA SMART PUMP FRN SIGMA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Disability