BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3240837 · Received July 17, 2013

    Report

    Report Number
    1314492-2013-01340
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 19, 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 (B)(4). THE REPORTED "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 SENSOR AND DOWNSTREAM TUBING GUIDE WERE REPLACED.

    Description of Event or Problem · 1

    DURING THE EVAL OF A RETURNED SPECTRUM INFUSION PUMP, 25 OCCURRENCES OF A "DOWNSTREAM OCCLUSION" 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. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332472 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1