BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3896413 · Received January 16, 2014

    Report

    Report Number
    1314492-2014-03498
    Event Type
    Malfunction
    Date Received
    January 16, 2014
    Date of Event
    December 1, 2013
    Report Date
    December 20, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF NO.:(B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY BAXTER. THIS COMPLAINT WAS OPENED DURING THE INVESTIGATION OF COMPLAINT (B)(4). THE "DOWNSTREAM OCCLUSION" ALARMS WERE CONFIRMED THROUGH THE EVENT HISTORY LOG REVIEW. THE CAUSE WAS UNDETERMINED. IF ANY ADDITIONAL INFO IS RECEIVED A FOLLOW UP WILL BE SENT. THE FORCE SENSOR PUSHER, FORCE SENSOR GASKET AND DOWNSTREAM TUBING GUIDE WERE REPLACED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED SPECTRUM INFUSION PUMP, 199 OCCURRENCES OF "DOWNSTREAM OCCLUSION" ALARM WERE IDENTIFIED IN THE EVENT HISTORY LOG. ANY PT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION IS UNKNOWN SINCE THESE ITEMS WERE FOUND DURING EVALUATION OF THE DEVICE. NO ADDITIONAL INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44121 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP. 35700

    Patients

    Seq Age Sex Outcome Treatment
    1