BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3101838 · Received May 1, 2013

    Report

    Report Number
    1314492-2013-00474
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 2, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS REC'D AND EVALUATED BY BAXTER. THE EVAL CONFIRMED THAT THE PUMP CONSTANTLY ALARMS "AIR-IN-LINE," CAUSED BY A FAILED ULTRASONIC SENSOR. THE BAXTER DEVICE EVAL FOUND THE LOWER READING ON THE ULTRASONIC SENSOR WITH A FLUID FILLED TUBE TO BE BELOW SPECIFICATION WHICH WOULD MAKE THE PUMP MORE SENSITIVE TO AIR AND UPSTREAM OCCLUSION ALARMS. THE UPSTREAM SENSOR WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP CONSTANTLY ALARMED "AIR-IN-LINE" DURING AN INFUSION IN THE EMERGENCY ROOM. IT WAS ADDITIONALLY REPORTED THAT THE ALARM WAS CONFIRMED THROUGH TESTING AT THE FACILITY. IT WAS ALSO REPORTED THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190373 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1