BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3935374 · Received February 3, 2014

    Report

    Report Number
    1314492-2014-05686
    Event Type
    Malfunction
    Date Received
    February 3, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 7, 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 TO BAXTER AND AN EVALUATION WAS PERFORMED. EVALUATION CONFIRMED THE REPORTED SYMPTOM OF SYSTEM ERROR 231 THROUGH THE HISTORY LOG, BUT COULD NOT REPRODUCE IT. REVIEW OF KNOWN CONTRIBUTORS LED TO THE DETERMINATION THAT THE MOTOR ASSEMBLY WAS THE FAILING COMPONENT. THE MOTOR ASSEMBLY WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP ALARMED FOR SYSTEM ERROR 231 WHILE ON A PATIENT. ANY PATIENT INJURY IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71453 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1