BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3935567 · Received February 3, 2014

    Report

    Report Number
    1314492-2014-05895
    Event Type
    Malfunction
    Date Received
    February 3, 2014
    Date of Event
    December 1, 2013
    Report Date
    January 6, 2014
    Manufacturer
    BAXTER HEALTHCARE CORP
    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 RETURNED TO BAXTER AND AN EVALUATION WAS PERFORMED. EVALUATION CONFIRMED THE "UPSTREAM OCCLUSION" ALARMS FOUND WITHIN THE HISTORY LOG, BUT COULD NOT REPRODUCE IT. THE PUMP WAS RE-CALIBRATED TO ENSURE CONTINUED ACCURATE OCCLUSION DETECTION.

    Description of Event or Problem · 1

    DURING BAXTER'S DEVICE EVALUATION, MULTIPLE OCCURRENCES OF "UPSTREAM OCCLUSION" WERE IDENTIFIED WITHIN THE HISTORY LOG. THERE WAS NO PT INVOLVEMENT AS THIS WAS FOUND DURING EVALUATION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69975 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1