BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 4516473 · Received August 21, 2014

    Report

    Report Number
    1314492-2014-52106
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Date of Event
    July 1, 2014
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 (B)(4). THE DOWNSTREAM OCCLUSION ALARMS WERE CONFIRMED THROUGH THE EVENT HISTORY LOG REVIEW. THE CAUSE WAS UNDETERMINED. IF ANY ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP 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, 140 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. SPECTRUM INFUSION PUMP INFUSION PUMP BAXTER HEALTHCARE CORP

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507749 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1