BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA

    MDR report key: 2628884 · Received June 20, 2012

    Report

    Report Number
    MW5025922
    Event Type
    Malfunction
    Date Received
    June 20, 2012
    Report Date
    June 20, 2012
    Manufacturer
    SIGMA
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    SIGMA SPECTRUM INFUSION PUMP-EXPANDED CLASS 1 RECALL - SERIAL NUMBERS RANGE FROM (B)(4). THIS RECALL INCLUDES ANY PUMP MANUFACTURED FROM 01/18/2005 THROUGH 11/01/2010 UNLESS PREVIOUSLY SERVICED FOR THIS ISSUE. THESE UNITS MAY FAIL SUDDENLY CAUSING INACCURATE FLOW CONDITIONS DURING USE, RANGING FROM BACK FLOW TO OVER INFUSION, INCLUDING FREE FLOW. NO ALARM IS ISSUED POSSIBLY RESULTING IN SERIOUS INJURY OR DEATH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1