BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3062554 · Received March 19, 2013

    Report

    Report Number
    1314492-2013-00263
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    January 12, 2012
    Report Date
    February 19, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED AND EVALUATED BY BAXTER. THE EVALUATION WAS UNABLE TO CONFIRM THAT THE DEVICE WOULD NOT CORRECTLY CHANGE FROM THE SECONDARY INFUSION RATE TO THE PRIMARY INFUSION RATE. REVIEW OF THE DEVICE HISTORY LOG SHOWS THAT ON THE LAST PROGRAMMED SECONDARY INFUSION, WHEN THE INFUSION WAS COMPLETE, THE DEVICE CORRECTLY CHANGED TO THE PRIMARY INFUSION RATE. ADDITIONALLY A FLOW RATE TEST WAS PERFORMED PER THE SPECTRUM PREVENTIVE MAINTENANCE PROCEDURE AND THE DEVICE WAS FOUND TO DELIVER WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP WAS PROGRAMMED TO DELIVER A SECONDARY INFUSION (MEDICATION, PROGRAMMED AMOUNT AND DELIVERY RATE UNK). THE CUSTOMER STATED THAT WHEN THE SECONDARY INFUSION WAS COMPLETE, THE PUMP FAILED TO CHANGE FROM THE PROGRAMMED SECONDARY INFUSION RATE TO THE PROGRAMMED PRIMARY INFUSION RATE. IT WAS ALSO REPORTED THAT THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113065 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1