BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3935124 · Received February 3, 2014

    Report

    Report Number
    1314492-2014-05615
    Event Type
    Malfunction
    Date Received
    February 3, 2014
    Date of Event
    December 23, 2013
    Report Date
    January 7, 2014
    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

    MANUFACTURER REF NO.; (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND EVALUATED. THE UNIT WAS RECEIVED INOPERABLE DUE TO A CONSTANT "DOOR NOT FULLY LATCHED" MESSAGE CAUSED BY A LOOSE UPPER LINK SCREW. THE SCREW WAS ADJUSTED DURING EVALUATION WITH THE DOOR PERFORMING AS EXPECTED. THE SCREWS WERE REPLACED DURING THE REPAIR PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP HAS A DOOR NOT FULLY LATCHED MESSAGE WHICH WAS FOUND DURING CHEMOTHERAPY. IT WAS ALSO REPORTED THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69741 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1