BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3874047 · Received January 24, 2014

    Report

    Report Number
    1314492-2014-04468
    Event Type
    Malfunction
    Date Received
    January 24, 2014
    Date of Event
    December 19, 2013
    Report Date
    December 27, 2013
    Manufacturer
    BAXTER HLTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF: (B)(4). BAXTER'S ENGINEERING INVESTIGATION IS IN PROGRESS. WHEN COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP CHANGED THE PROGRAMMED DOSE AND RATE WITHOUT USER INPUT. AN EVENT HISTORY LOG SUPPLIED BY THE CUSTOMER SHOWS THAT THE PUMP WAS PROGRAMMED TO DELIVER AT A RATE OF 7.5ML/HR AND THE RATE WAS CHANGED BY THE USER TO DELIVER AT 6ML/HR. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56088 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HLTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1