BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM

    MDR report key: 2699380 · Received August 8, 2012

    Report

    Report Number
    2699380
    Event Type
    Malfunction
    Date Received
    August 8, 2012
    Date of Event
    August 8, 2012
    Report Date
    August 8, 2012
    Manufacturer
    SIGMA INTERNATIONAL
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SD, US

    Narratives

    Description of Event or Problem · 1

    WHILE IN PROCESS OF INVESTIGATING AN ISSUE WITH ONE OF THESE PUMPS, IT CAME TO OUR ATTENTION THAT THEY OPERATE BEHIND THE SCENES ON GMT GREENWICH MEAN TIME AND THE INTERNAL CLOCK CAN NOT BE RESET TO OUR LOCAL TIME. THUS, THE ALARM RECORD MAY BE ACCURATE TO THE MINUTE, BUT IT IS NOT ACCURATE TO THE HOUR AND MAKES INVESTIGATING THE SITUATION OF WHETHER IT ALARMED WHEN IT SHOULD HAVE FOR A PROBLEM WITH THE IV VERY DIFFICULT TO FIND. THE INTERNAL CLOCK SHOULD BE ADJUSTABLE TO OUR LOCAL TIME, SO IF AN IV DRIP IS OCCLUDED, THE UPSTREAM OCCLUSION ALARM RECORD SHOWS LOCAL TIME NOT GMT.======================MANUFACTURER RESPONSE FOR IV SMART PUMPS, SIGMA SPECTRUM IV PUMP (PER SITE REPORTER).======================WHEN BIO MED QUESTIONED WHY OUR ATTEMPTS TO RE-SET THE TIME TO CENTRAL TIME WOULD NOT STAY, THEY WERE TOLD THAT THE INTERNAL CLOCKS ARE SET TO GMT ON ALL THE SIGMA SPECTRUM SMART PUMPS FOR STANDARDIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRUM INFUSION PUMP FRN SIGMA INTERNATIONAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *