BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 5123118 · Received October 2, 2015

    Report

    Report Number
    1314492-2015-09714
    Event Type
    Malfunction
    Date Received
    October 2, 2015
    Date of Event
    August 1, 2015
    Report Date
    September 10, 2015
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER EVALUATED THE DEVICE AND FOUND THAT THE UPSTREAM SENSOR WAS OUT OF SPECIFICATION. IT WAS DETERMINED THAT THIS FAILING PART CAUSED THE FALSE AIR IN LINE ALARMS AND HAS BEEN REPLACED.

    Description of Event or Problem · 1

    DURING REVIEW OF THE EVENT HISTORY LOG IT WAS DETERMINED THAT A REPEATING PATTERN OF AIR-IN-LINE ALARMS SUGGESTS THAT THE DEVICE WAS FALSELY ALARMING FOR AIR-IN-LINE. THE OCCURRENCES SUGGEST A DEVICE MALFUNCTION. ANY PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654483 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1