BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3871371 · Received January 29, 2014

    Report

    Report Number
    1314492-2014-05003
    Event Type
    Malfunction
    Date Received
    January 29, 2014
    Date of Event
    January 2, 2014
    Report Date
    January 2, 2014
    Manufacturer
    BAXTER HEALTHCARE CORP
    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

    MANUFACTURER REF NO: (B)(4). THE DEVICE WAS RETURNED TO AND EVALUATED BY BAXTER. THIS COMPLAINT WAS OPENED DURING THE INVESTIGATION OF COMPLAINT (B)(4). THE IDENTIFIED "SYSTEM ERROR 105" ALARM WAS CONFIRMED AND REPRODUCED DURING EVALUATION CAUSED BY A FAILED MOTOR (FLEX). THE MOTOR ASSEMBLY WAS REPLACED.

    Description of Event or Problem · 1

    DURING THE EVALUATION OF A RETURNED SPECTRUM INFUSION PUMP, BAXTER EXPERIENCED SYSTEM ERROR 105 ALARM. ANY PATIENT INVOLVEMENT OR MEDICAL INTERVENTION IS UNKNOWN SINCE THIS WAS FOUND DURING EVALUATION OF THE DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63690 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1