BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM

    MDR report key: 2171950 · Received July 13, 2011

    Report

    Report Number
    2171950
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    July 10, 2011
    Report Date
    July 13, 2011
    Manufacturer
    SIGMA
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    NEW INSULIN BAG HUNG ON PATIENT WITH SIGMA IV PUMP. PUMP ALARMED A COUPLE OF MINUTES LATER. DOOR WAS CLOSED, ALARMING 'UNABLE TO RUN NO TUBING LOADED'. THE TUBING WAS CHECKED, DOOR WAS OPENED AND INSULIN BAG NOTED TO BE ONLY HALF FULL. THE TUBING WAS IMMEDIATELY REMOVED FROM THE PUMP AND DISCONNECTED FROM THE PATIENT. DOCTOR NOTIFIED, MEDICATIONS GIVEN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention