BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3253620 · Received July 15, 2013

    Report

    Report Number
    1314492-2013-01208
    Event Type
    Malfunction
    Date Received
    July 15, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 20, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 REPORTED "AIR-IN-LINE" 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 UPSTREAM SENSOR WAS REPLACED.

    Description of Event or Problem · 1

    DURING THE EVALUATION OF A RETURNED SPECTRUM INFUSION PUMP, 57 OCCURRENCES OF AN "AIR-IN-LINE" ALARM WERE IDENTIFIED IN THE EVENT HISTORY LOG. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED SINCE THESE ITEMS WERE FOUND DURING EVALUATION OF THE DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326017 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP. 35700

    Patients

    Seq Age Sex Outcome Treatment
    1