BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3935379 · Received February 3, 2014

    Report

    Report Number
    1314492-2014-05687
    Event Type
    Malfunction
    Date Received
    February 3, 2014
    Date of Event
    December 1, 2013
    Report Date
    January 7, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND AN EVALUATION WAS PERFORMED. THE EVALUATION CONFIRMED AND REPRODUCED THE REPORTED SYMPTOM SYSTEM ERROR 105 CAUSED BY THE GEARS AND MOTOR ALIGNMENT BEING OFF CENTER DUE TO SEVERED MOTOR MOUNT SCREWS. THE DEVICE HAS BEEN RETIRED FROM SERVICE.

    Description of Event or Problem · 1

    DURING BAXTER'S DEVICE EVALUATION, THE DEVICE DISPLAYED A "SYSTEM ERROR 105" ALARM. THERE WAS NO PATIENT INVOLVEMENT AS THIS WAS FOUND DURING EVALUATION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71480 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1