BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA SMART PUMP

    MDR report key: 3840204 · Received May 22, 2014

    Report

    Report Number
    MW5036331
    Event Type
    Injury
    Date Received
    May 22, 2014
    Date of Event
    May 10, 2014
    Report Date
    May 21, 2014
    Manufacturer
    BAXTER
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    IV PUMP INDICATED VOLUME OF PAIN MEDICINE WAS INFUSING. IT WAS NOT. THE PATIENT WAS PARALYZED AND VENTILATED. SHE COULD NOT INDICATE THAT SHE WAS EXPERIENCING PAIN. THE PUMP WAS USED FROM (B)(6) 2014. A NURSE HUNG AN INTRAVENOUS BAG OF FENTANYL TO RUN CONTINUOUSLY IN ORDER TO CONTROL THE PATIENT'S PAIN. THE PUMP INITIALLY ALARMED DUE TO AN UPSTREAM INFUSION PROBLEM. THE NURSE CHECKED THE PUMP, BUT DID NOT SEE A PROBLEM AND SILENCED THE ALARM. IT ALARMED A SECOND TIME AND THE ALARM WAS SILENCED. IT DID NOT ALARM AGAIN UNTIL THE FOLLOWING DAY WHEN THE PATIENT WAS TO RECEIVE A BOLUS OF FENTANYL. THE NURSE ON THAT DAY DID NOT SEE A PROBLEM AND SILENCED THE ALARM. THE PUMP DID NOT ALARM AGAIN. ON (B)(6), A NURSE WAS CHECKING THE LINE AND DISCOVERED THAT THE UPPER CLAMP WAS CLOSED ABOVE THE PUMP. THE PUMP INDICATED THAT MEDICINE HAD BEEN INFUSING. THE PATIENT HAD RECEIVED NO PAIN MEDICATION FOR OVER 40 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304247 SIGMA SMART PUMP SIGMA SMART PUMP FRN BAXTER 865772

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other FENTANYL TO RUN CONTINUOUSLY