BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA 8000

    MDR report key: 1024250 · Received March 27, 2008

    Report

    Report Number
    1314492-2008-00001
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    November 12, 2007
    Report Date
    March 31, 2008
    Manufacturer
    SIGMA INTL.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT RECEIVED OPERABLE AND FAILS FLOW RATE ACCURACY TEST WITH ERRATIC DELIVERIES. A CONTAMINATED PUMP ASSEMBLY WAS DETERMINED TO BE THE CAUSE OF THE REPORTED OVER INFUSION. PUMP ASSEMBLY WAS CLEANED AND GREASED AND PERFORMS WITHIN SPECIFICATIONS OF THE DEVICE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE PUMP HAD OVER INFUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA 8000 INFUSION PUMP FRN SIGMA INTL. 8000 54875R

    Patients

    Seq Age Sex Outcome Treatment
    1