BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3853349 · Received January 23, 2014

    Report

    Report Number
    1314492-2014-04464
    Event Type
    Malfunction
    Date Received
    January 23, 2014
    Date of Event
    December 1, 2013
    Report Date
    December 30, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    BAXTER RECEIVED AND EVALUATED THE DEVICE THE SYMPTOM NO AUDIO WAS CONFIRMED AND REPRODUCED. THE J-6 CONNECTOR CLIP WAS DEPRESSED CAUSING AN INTERMITTENT CONNECTION WITH THE BACK FLEX TAIL. AFTER THE TAIL WAS INSTALLED PROPERLY THE UNIT PERFORMED AS EXPECTED, WITH AUDIO.

    Description of Event or Problem · 1

    IT WAS FOUND DURING BAXTER'S TESTING THAT A PUMP HAD NO AUDIO. THERE WAS NO PT INVOLVEMENT SINCE THE ERROR WAS FOUND DURING TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55166 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1