BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3801772 · Received January 8, 2014

    Report

    Report Number
    1314492-2014-01320
    Event Type
    Malfunction
    Date Received
    January 8, 2014
    Date of Event
    November 1, 2013
    Report Date
    December 11, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 "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 FORCE SENSOR ASSEMBLY, FORCE SENSOR GASKET, FORCE SENSOR PUSHER, DOWNSTREAM TUBING GUIDE, AND INPUT/OUTPUT PRINTED CIRCUIT BOARD WERE REPLACED.

    Description of Event or Problem · 1

    DURING THE EVAL OF A RETURNED SPECTRUM INFUSION PUMP, 217 OCCURRENCES OF "DOWNSTREAM OCCLUSION" ALARMS WERE IDENTIFIED IN THE EVENT HISTORY LOG. ANY PT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION IS UNK 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
    13520 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1