BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3071079 · Received April 8, 2013

    Report

    Report Number
    1314492-2013-00364
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 10, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS RECEIVED FROM A PT FAMILY MEMBER AND THEREFORE THE DEVICE SERIAL NUMBER IS UNKNOWN, AND NO CONTACT INFORMATION WAS PROVIDED TO BAXTER. IF THE DEVICE IS IDENTIFIED AND RETURNED, AN EVALUATION WILL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INFUSION, THE DEVICE ALARMED 5 TIMES FOR AN UPSTREAM OCCLUSION (MEDICATION, PROGRAMMED AMOUNT AND DELIVERY RATE UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144539 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR