BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA SPECTRUM SMART PUMP

    MDR report key: 2021732 · Received March 14, 2011

    Report

    Report Number
    MW5019799
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 9, 2011
    Manufacturer
    SIGMA INTL
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT RECEIVING IV OF N/S AT 75ML/HR. THE NURSE ENTERED THE ROOM AND NOTED THAT THE SIGMA PUMP ON WHICH THE IV FLUID WAS INFUSING WAS OFF. THE NURSE ATTEMPTED TO RESTART THE PUMP BUT IT WOULD NOT TURN ON. THE NURSE SAID THAT THERE HAD BEEN NO ALARM. THE NURSE HAD BEEN IN THE ROOM APPROXIMATELY 45 MINUTES PRIOR AND THE PUMP HAD BEEN RUNNING AT THAT TIME. THE PUMP WAS REMOVED FROM SERVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other