BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PU,P

    MDR report key: 4486795 · Received August 6, 2014

    Report

    Report Number
    1314492-2014-48332
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 23, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 SYSTEM ERROR 105 ALARMS WERE CONFIRMED THROUGH AN EVENT HISTORY LOG REVIEW. THE CAUSE WAS UNDETERMINED. IF ANY ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP WILL BE SENT. THE ACETAL GEAR WAS REPLACED.

    Description of Event or Problem · 1

    DURING THE EVALUATION OF A RETURNED SPECTRUM INFUSION PUMP, 4 OCCURRENCES OF 'SYSTEM ERROR 105' ALARMS WERE IDENTIFIED IN THE EVENT HISTORY LOG. ANY PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION IS UNKNOWN SINCE THESE ITEMS WERE FOUND DURING EVALUATION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462418 SPECTRUM INFUSION PU,P INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1