BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3063150 · Received February 27, 2013

    Report

    Report Number
    1314492-2013-00163
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 31, 2013
    Report Date
    February 1, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO BAXTER FOR EVAL AND THEREFORE AN EVAL COULD NOT BE COMPLETED. IF THE DEVICE IS RETURNED, AN EVAL WILL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED. KNOWN CONDITIONS RESULTING IN FLOW FROM THE PRIMARY CONTAINER DURING A SECONDARY INFUSION SEGMENT INCLUDE AN INADEQUATE HEIGHT DIFFERENTIAL BETWEEN THE PRIMARY AND THE SECONDARY IV CONTAINERS, OR A HIGH FLOW RATE (TYPICALLY ABOVE 300 ML/HR). THE SPECTRUM OPERATORS MANUAL RECOMMENDS THE PRIMARY IV CONTAINER BE PLACED 20 INCHES BELOW THE SECONDARY IV CONTAINER TO PROVIDE A GRAVITY ADVANTAGE THAT ALLOWS FLOW FROM THE SECONDARY IV CONTAINER ONLY, AND WARNS THE USER OF THE POSSIBILITY OF PRIMARY IV CONTAINER SIPHONING WITH FLOW RATES ABOVE 300 ML/HR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SECONDARY INFUSION, A PUMP WAS SIMULTANEOUSLY DELIVERING FLUID FROM THE PRIMARY BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85288 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1