BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3040554 · Received March 11, 2013

    Report

    Report Number
    1314492-2013-00218
    Event Type
    Malfunction
    Date Received
    March 11, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 10, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO BAXTER FOR EVALUATION AND THEREFORE AN EVALUATION COULD NOT BE COMPLETED. IF THE DEVICE IS RETURNED, AN EVALUATION WILL BE COMPLETED AND A SUPPLEMENTAL REPORT WIL BE SUBMITTED. BAXTER ATTEMPTED TO CONTACT THE CUSTOMER ON MULTIPLE OCCASIONS TO ACQUIRE ADDITIONAL EVENT INFORMATION WITHOUT SUCCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP OVER INFUSED A CHEMOTHERAPY MEDICATION. THE CUSTOMER STATED THAT THE PUMP WAS PROGRAMMED TO INFUSE IN 24 HOURS, BUT THE INFUSION WAS COMPLETED IN 20 HOURS (PROGRAMMED AMOUNT AND DELIVERY RATE UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102467 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1