BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 4905689 · Received July 6, 2015

    Report

    Report Number
    1314492-2015-07314
    Event Type
    Malfunction
    Date Received
    July 6, 2015
    Date of Event
    June 11, 2015
    Report Date
    June 11, 2015
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. THE DEVICE WAS FOUND OUT OF SPEC IN RELATION TO THE SYMPTOM WHICH WAS NOT REPRODUCED. THE SYSTEM ERROR 105 WAS CONFIRMED THROUGH REVIEW OF THE EVENT HISTORY LOG. EVAL FOUND EXTENSIVE CORROSION ON THE MOTOR FLEX AND INPUT/OUTPUT PRINTED CIRCUIT BOARD (I/O BOARD) DUE TO FLUID INTRUSION. THE OBSERVED CORROSION RENDERED THE DEVICE IRREPARABLE. THE DEVICE WAS REMOVED FROM SERVICE.

    Description of Event or Problem · 1

    DURING BAXTER'S EVAL OF A SPECTRUM PUMP DISPLAYED SYSTEM ERROR 322. IT WAS ALSO REPORTED THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436871 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1