BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3896378 · Received January 16, 2014

    Report

    Report Number
    1314492-2014-03478
    Event Type
    Malfunction
    Date Received
    January 16, 2014
    Date of Event
    December 1, 2013
    Report Date
    December 20, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY BAXTER. THIS COMPLAINT WAS OPENED DURING THE INVESTIGATION OF COMPLAINT (B)(4). THE IDENTIFIED "UPSTREAM OCCLUSION" ALARMS WERE CONFIRMED THROUGH THE EVENT HISTORY LOG REVIEW. THE CAUSE WAS UNDETERMINED. IF ANY ADD'L INFO IS REC'D, A F/U WILL BE SENT. THE DOWNSTREAM TUBING GUIDE, FORCE SENSOR GASKET, AND FORCE SENSOR PUSHER WERE REPLACED.

    Description of Event or Problem · 1

    DURING THE EVALUATION OF A RETURNED SPECTRUM INFUSION PUMP, 398 OCCURRENCES OF "DOWNSTREAM OCCLUSION" ALARMS WERE IDENTIFIED IN THE EVENT HISTORY LOG. ANY PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION IS UNKNOWN SINCE THESE ITEMS WERE FOUND DURING EVALUATION OF THE DEVICE. NO ADD'L INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44124 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1