BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3222009 · Received July 5, 2013

    Report

    Report Number
    1314492-2013-01038
    Event Type
    Malfunction
    Date Received
    July 5, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 7, 2013
    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). THE DEVICE WAS RETURNED AND EVALUATED BY BAXTER. THE INVESTIGATION WAS ABLE TO REPRODUCE THE REPORTED SYMPTOM. THE CAUSE OF THE REPORTED SYMPTOM COULD NOT BE IDENTIFIED. THE UPPER AUXILIARY ASSEMBLY AND LOWER AUXILIARY ASSEMBLY HAVE BEEN REPLACED AS THEY ARE KNOWN CONTRIBUTORS TO THE REPORTED SYMPTOM. THE CUSTOMER WAS ISSUED A REPLACEMENT DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP ALARMED FOR SYSTEM ERROR 322 WHILE IN THE CRITICAL CARE UNIT. THE CUSTOMER ALSO STATED THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307119 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1