BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3780017 · Received January 6, 2014

    Report

    Report Number
    1314492-2014-00871
    Event Type
    Malfunction
    Date Received
    January 6, 2014
    Date of Event
    December 1, 2013
    Report Date
    December 9, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP
    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). BAXTER RECEIVED AND EVALUATED THE DEVICE. THE SYMPTOM DOES NOT DETECT AN UPSTREAM OCCLUSION WAS CONFIRMED AND REPRODUCED. THE UPSTREAM SENSOR WAS CALIBRATED TO ENSURE ACCURATE DETECTION. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    IT WAS FOUND DURING BAXTER'S TESTING THAT A PUMP WAS NOT DETECTING AN UPSTREAM OCCLUSION. THERE WAS NO PT INVOLVEMENT SINCE THE ERROR WAS FOUND DURING TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8391 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1