BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 4034040 · Received March 21, 2014

    Report

    Report Number
    1314492-2014-16287
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Date of Event
    February 1, 2014
    Report Date
    February 25, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER FOR EVAL. THE INVESTIGATION HAS NOT BEEN COMPLETED AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE PROVIDED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP ALARMED DOOR NOT FULLY LATCHED. IT WAS ALSO REPORTED THERE WAS NO PT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170519 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1