BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA SPECTRUM INFUSION PUMP

    MDR report key: 1157863 · Received September 11, 2008

    Report

    Report Number
    MW5008267
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    August 27, 2008
    Report Date
    September 4, 2008
    Manufacturer
    SIGMA INTERNATIONAL
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A MALE ADMITTED TO MICU WITH CVA. PMH INCLUDES ASTHMA, CHRONIC BRONCHITIS, HTN, HYPERCHOLESTEROLEMIA, GERD, BPH, PARALYZED VOCAL CORD, VT S/P AICD, ATRIAL FIBRILLATION, ANEMIA AND POSSIBLE CHRONIC PANCREATITIS. THE PT WAS RECEIVING AN IV OF NORMAL SALINE AT 10CC/HR VIA SIGMA SPECTRUM INFUSION PUMP. THE NURSE WAS IN THE ROOM WITH THE PT WHEN SHE HEARD A LOUD ALARM COMING FROM THE PUMP. THE NURSE CHECKED THE PUMP AND SAW ZERO'S ACROSS THE TOP HALF OF THE PUMP. THERE WAS A MESSAGE ON THE BOTTOM OF THE SCREEN WHICH STATED "UNPLUG THE PUMP AND REMOVE THE BATTERY." THE PUMP WAS TAKEN OUT OF SERVICE AND THE BIOMEDICAL ENGINEER WAS NOTIFIED. THE COMPANY WAS NOTIFIED BIOMEDICAL ENGINEERING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other