BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3935658 · Received February 3, 2014

    Report

    Report Number
    1314492-2014-05635
    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
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND AN EVAL WAS PERFORMED. THE EVAL CONFIRMED AND REPRODUCED THE REPORTED SYMPTOM SYSTEM ERROR 105 CAUSED BY FAILED MOTOR FLEX. THE MOTOR ASSEMBLY WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP ALARMED SYSTEM ERROR 105. IT WAS ALSO REPORTED THAT THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69885 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1