BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3240913 · Received July 17, 2013

    Report

    Report Number
    1314492-2013-01359
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 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 (B)(4). THE REPORTED "AIR-IN-LINE" ALARMS WERE CONFIRMED THROUGH THE EVENT HISTORY LOG REVIEW. THE CAUSE WAS UNDETERMINED. IF ANY ADD'L INFO IS RECEIVED, A F/U WILL BE SENT. THE ULTRASONIC SENSOR WAS REPLACED.

    Description of Event or Problem · 1

    DURING THE EVAL OF A RETURNED SPECTRUM INFUSION PUMP, 52 OCCURRENCE OF "AIR-IN-LINE" ALARM WERE IDENTIFIED IN THE EVENT HISTORY LOG. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION REQUIRED SINCE THESE ITEMS WERE FOUND DURING EVAL OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332822 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1