BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3792699 · Received January 2, 2014

    Report

    Report Number
    1314492-2014-00016
    Event Type
    Malfunction
    Date Received
    January 2, 2014
    Date of Event
    December 1, 2013
    Report Date
    December 5, 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). BAXTER RECEIVED AND EVALUATED THIS DEVICE. THE REPORTED SYMPTOM OF "CONSTANT AIR IN LINE ALARMS" WAS CONFIRMED THROUGH REVIEW OF THE EVENT HISTORY LOG. THE DEVICE WAS RECEIVED INOPERABLE DUE TO CONSTANT "RELOAD SET" ALARMS CAUSED BY A FAILED UPSTREAM SENSOR. THE LOWER FLUID NUMBER READINGS FROM THE UPSTREAM SENSOR WERE BELOW SPECIFICATION, WHICH WOULD MAKE THE PUMP MORE SENSITIVE TO AIR AND UPSTREAM OCCLUSION ALARMS IF THE PUMP WERE ABLE TO RUN. THE UPSTREAM SENSOR WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP HAD "CONSTANT AIR IN LINE ALARMS." IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1839 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1