BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3003613 · Received February 11, 2013

    Report

    Report Number
    1314492-2013-00085
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    December 19, 2012
    Report Date
    January 15, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER EVALUATED THE DEVICE IN QUESTION AND A FLOW RATE TEST WAS PERFORMED PER THE SPECTRUM PREVENTIVE MAINTENANCE PROCEDURE AND THE DEVICE WAS FOUND TO DELIVER WITHIN SPECIFICATION. AN ADDITIONAL FLOW RATE TEST WAS PERFORMED USING THE EVENT INFUSION PARAMETERS FOUND IN THE HISTORY LOG (FOR A PERIOD OF 1 HOUR) AND THE DEVICE UNDER DELIVERED BY 7.76%. AFTER THE DEVICE WAS FLOW RATE TESTED, THE PUMP ALARMED FOR "RELOAD SET" AND SYSTEM ERROR 306, CAUSE BY A FAILED DOWNSTREAM SENSOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP WAS PROGRAMMED TO DELIVER 250 ML OF FENTANYL AT A RATE OF 2.5 ML/HR. AFTER 8 HOURS, IT WAS OBSERVED THAT ONLY 40ML OF FLUID REMAINED IN THE IV CONTAINER. IT WAS ALSO REPORTED THAT THERE WAS NO PT INJURY. THE CUSTOMER TESTED THE DEVICE 3 TIMES. IT WAS REPORTED THAT THE PUMP PASSED THE FIRST TEST; HOWEVER, IT IS UNCLEAR IF THE DEVICE PASSED THE 2ND AND 3RD TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60519 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1