BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM PUMP

    MDR report key: 3913008 · Received January 14, 2014

    Report

    Report Number
    1314492-2014-03126
    Event Type
    Malfunction
    Date Received
    January 14, 2014
    Date of Event
    December 1, 2013
    Report Date
    December 18, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER IS CONTINUING TO INVESTIGATE THE EVENT. WHEN THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING BAXTER'S INITIAL EVALUATION OF A SPECTRUM PUMP, IT WAS FOUND TO FALSELY ALARM FOR UPSTREAM OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36248 SPECTRUM PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1