BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3553530 · Received October 30, 2013

    Report

    Report Number
    1314492-2013-13414
    Event Type
    Malfunction
    Date Received
    October 30, 2013
    Date of Event
    October 1, 2013
    Report Date
    October 3, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP
    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

    (B)(4). THE DEVICE WAS RECEIVED AND EVALUATED BY BAXTER. INITIAL EVALUATION FOUND THAT THIS PUMP FAILED THE 40 ML/HR UPSTREAM OCCLUSION TEST. THE UNIT PASSED ADDITIONAL UPSTREAM OCCLUSION TESTING PER BAXTER'S SERVICE PROCEDURE. THE PUMP WILL BE CALIBRATED TO ENSURE ACCURATE OCCLUSION DETECTION.

    Description of Event or Problem · 1

    DURING BAXTER'S EVALUATION OF THIS SPECTRUM PUMP FOR A SEPARATE SYMPTOM, IT WAS FOUND THAT THIS DEVICE FAILED THE UPSTREAM OCCLUSION TEST AT A RATE OF 40 ML/HR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557794 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1