BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3880266 · Received January 30, 2014

    Report

    Report Number
    1314492-2014-05113
    Event Type
    Malfunction
    Date Received
    January 30, 2014
    Date of Event
    January 3, 2014
    Report Date
    January 3, 2014
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. IT WAS FOUND OUT OF SPEC WITH RESPECT TO DOOR NOT FULLY LATCHED MESSAGE. THESE DISPLAYED DURING THE EVAL AND FOUND TO BE CAUSED BY A FAILED LOWER LINK SWITCH DUE TO DEBRIS. THE DEBRIS WAS REMOVED. THE LOWER AUXILIARY ASSEMBLY WAS REPLACED.

    Description of Event or Problem · 1

    DURING BAXTER'S EVAL OF A SPECTRUM PUMP, IT DISPLAYED A DOOR NOT FULLY LATCHED MESSAGE, WHEN THE DOOR WAS CLOSED. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66441 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1