BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3253611 · Received July 15, 2013

    Report

    Report Number
    1314492-2013-01194
    Event Type
    Malfunction
    Date Received
    July 15, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 19, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER, AND THE EVALUATION IS COMPLETE. THIS COMPLAINT IS AN ANCILLARY SERVICE EVENT OPENED DURING INVESTIGATION OF (B)(4). THE "UPSTREAM OCCLUSION" ALARMS WERE CONFIRMED THROUGH AN EVENT HISTORY LOG REVIEW. THE ULTRASONIC SENSOR WAS FOUND TO BE OUT OF SPECIFICATION AND HAS BEEN REPLACED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED SPECTRUM INFUSION PUMP, 14 OCCURRENCES OF "UPSTREAM OCCLUSION" ALARM WERE IDENTIFIED IN THE HISTORY LOG WHICH INDICATES A POTENTIAL MALFUNCTION OF THE DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326112 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1