BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA SPECTRUM SMART PUMP

    MDR report key: 2467244 · Received February 21, 2012

    Report

    Report Number
    MW5024322
    Event Type
    Malfunction
    Date Received
    February 21, 2012
    Date of Event
    February 2, 2012
    Report Date
    February 13, 2012
    Manufacturer
    SIGMA
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) OLD, BROUGHT TO THE EMERGENCY DEPARTMENT WITH CHEST DISCOMFORT. SHE WAS STARTED ON A HEPARIN DRIP USING THE CARDIAC PROTOCOL. THE NURSE SET THE BOLUS TO RUN ON THE SIGMA SPECTRUM PUMP. WITHIN A MINUTE OF STARTING THE BOLUS, THE PUMP BEEPED AND STOPPED. THERE WAS AN ERROR MESSAGE. THE NURSE FOLLOWED THE DIRECTIONS ON THE ERROR MESSAGE: STOP PUMP, TURN THE PUMP OFF, RESTART THE PUMP. WHEN THE NURSE RESTARTED THE PUMP, PROGRAMMED DOSE OF HEPARIN HAD BEEN ERASED. THE NURSE WAS NOT ABLE TO RETRIEVE ANY INFORMATION ABOUT HOW MUCH OF THE BOLUS HAD INFUSED. SHE NOTIFIED THE PHYSICIAN AND IT WAS DECIDED TO NOT GIVE THE BOLUS SINCE IT WAS NOT KNOWN HOW MUCH HAD BEEN GIVEN. THE HEPARIN CONTINUOUS INFUSION WAS STARTED ON A DIFFERENT PUMP. THE PUMP IN QUESTION WAS SEQUESTERED AND OUR BIOMEDICAL DEPARTMENT WAS NOTIFIED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Other