BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3012634 · Received February 21, 2013

    Report

    Report Number
    1314492-2013-00141
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Report Date
    January 23, 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

    MFR REFERENCE NUMBER: (B)(4). THE DEVICE WAS NOT RETURNED TO BAXTER FOR EVAL AND THEREFORE, AN EVAL COULD NOT BE COMPLETED. IF THE DEVICE IS RETURNED, AN EVAL WILL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED. AT THIS TIME, THE DATE OF EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP WAS MEANT TO DELIVER FLUID TO A PT OVER TWO HOURS (MEDICATION, PROGRAMMED AMOUNT, AND DELIVERY RATE UNKNOWN). THE CUSTOMER STATED THAT THE DEVICE WAS PROGRAMMED INCORRECTLY AND DELIVERED THE ENTIRE MEDICATION IN ONE HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77389 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1