BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3071080 · Received April 8, 2013

    Report

    Report Number
    1314492-2013-00366
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 11, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE IN QUESTION. THE EVALUATION CONFIRMED THAT THE PUMP WILL POWER ON WHEN PRESSURE IS APPLIED TO THE PUMP DOOR. THIS WAS CAUSED BY A FAILED UPPER LATCH SWITCH. THE FAILED UPPER LATCH SWITCH WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP POWERS ON WITHOUT USER INPUT. IT WAS ALSO REPORTED THAT THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142850 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1