BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIGMA SPECTRUM PUMP

    MDR report key: 1492780 · Received October 6, 2009

    Report

    Report Number
    1314492-2009-00009
    Event Type
    Other
    Date Received
    October 6, 2009
    Date of Event
    September 13, 2009
    Report Date
    September 16, 2009
    Manufacturer
    SIGMA LLC
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECTRUM PUMP DESIGN REQUIRES APPROPRIATE BACK PRESSURE TO ENSURE NO MORE THAN 0.085ML OF FLUID IS DRAWN OUT DURING THE PUMPING CYCLE. THE APPROPRIATE AMOUNT OF BACK PRESSURE IS PRESENT WHEN THE PUMP US OPERATED WITHIN ITS INTENDED USE. THE INTENDED ROUTES OF ADMINISTRATION CONSIST OF THE FOLLOWING CLINICALLY ACCEPTABLE ROUTES: INTRAVENOUS, ARTERIAL, SUBCUTANEOUS, INTRATHECAL, EPIDURAL OR IRRIGATION OF FLUID SPACE (PER SIGMA SPECTRUM OPERATOR'S MANUAL). IF THE SPECTRUM PUMP IS PUMPING INTO AN AREA OF NEGATIVE BACK PRESSURE, AS WOULD BE ENCOUNTERED IN THE SETUP DESCRIBED IN THIS COMPLAINT, THE NEGATIVE BACK PRESSURE WOULD DRAW OUT MORE THAN THE EXPECTED 0.085ML PER CAM SHAFT REVOLUTION. THIS IS NOT A FREE-FLOW SITUATION (FLUID IS NOT DRAWN PAST CLOSED VALVES). THE NEGATIVE BACK PRESSURE IS SIMPLY DRAWING OUT A GREATER PORTION OF THE 0.242ML CONTAINED WITHIN THE PUMPING CHANNEL DURING EACH ROTATION OF THE CAMSHAFT THAN INTENDED. THE OVER INFUSION IS DIRECTLY RELATED TO THE NEGATIVE BACK PRESSURE WHICH OCCURRED DURING USE. THIS SITUATION IS AVOIDED BY OPERATING THE SIGMA SPECTRUM PUMPS ONLY WITHIN THE INTENDED USE DESCRIBED IN THE SIGMA SPECTRUM OPERATOR'S MANUAL.

    Description of Event or Problem · 1

    A SPECTRUM PUMP WAS INVOLVED IN AN OVER-INFUSION EVENT ON (B)(6)2009. THE PUMP WAS CONNECTED BETWEEN AN ARTIFICIAL KIDNEY AND A FRESENIUS DIALYSIS MACHINE (MODEL 2008K) ON THE NEGATIVE SIDE, DELIVERING APPROX 40% MORE NORMAL SALINE THEN PROGRAMMED TO DELIVER. NO SERIAL NUMBER WAS PROVIDED, AS THE PUMP THE PUMP WAS PLACED BACK INTO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA SPECTRUM PUMP INFUSION PUMP FRN SIGMA LLC 35700 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention