BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3780038 · Received January 6, 2014

    Report

    Report Number
    1314492-2014-00863
    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 OF "UNDETECTED DOWNSTREAM OCCLUSION" WAS FOUND DURING BAXTER'S INITIAL EVAL OF THIS PUMP. THE DOWNSTREAM SENSOR WAS CALIBRATED PER BAXTER'S SERVICE PROCEDURE TO ENSURE PROPER FUNCTIONALITY.

    Description of Event or Problem · 1

    DURING BAXTER'S INITIAL EVAL OF THIS SPECTRUM PUMP, IT WAS FOUND TO EXPERIENCE AN UNDETECTED DOWNSTREAM OCCLUSION ON THE HIGH PRESSURE SETTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8027 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1