BEUDAMED
    FDA Adverse Event Summary report: N

    CADD LEGACY PLUS

    MDR report key: 1833418 · Received August 22, 2010

    Report

    Report Number
    1833418
    Date Received
    August 22, 2010
    Date of Event
    April 3, 2010
    Report Date
    August 22, 2010
    Manufacturer
    SMITHS MEDICAL
    Product Code
    FRN
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FIVE NEW PUMPS ORDERED FROM SMITH'S MEDICAL FOR FLOLAN (EPOPROSTANIL) AND REMODULIN (TREPOSTINAL) PATIENTS. THE NEW PUMPS ORDERED WERE THE CADD-LEGACY PLUS MODELS THAT ARE PROGRAMMED WITH A RATE AS MG/HOUR. EXISTING PUMPS UTILIZED BY PATIENTS ON FLOLAN AND REMODULIN ARE CADD-LEGACY 1 WHICH IS PROGRAMMED AS MG/24 HOURS. BREAKDOWN IN COMMUNICATION ON THE PROCUREMENT OF THE PUMPS. IN ADDITION, WHEN THE PUMPS WERE RELEASED INTO SERVICE THE PUMPS WERE SET IN A LOCKED POSITION WITH THE INABILITY OF THE OPERATORS TO ENTER A VOLUME TO BE INFUSED OR RATE. OPERATIONS WERE NOT GIVEN THE UNLOCKING CODE NOR TOLD OF THE NEW PUMPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CADD LEGACY PLUS INFUSION PUMP FRN SMITHS MEDICAL MODEL 6500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *