BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-LEGACY

    MDR report key: 2992446 · Received February 27, 2013

    Report

    Report Number
    2992446
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 27, 2013
    Manufacturer
    SMITHS MEDICAL ASD, INC
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    NURSES (RNS) WERE TRYING TO CHANGE FLOLAN (EPOPROSTENOL SODIUM) AT MIDNIGHT AND THE PUMP WAS READING AIR DETECTED IN LINE. THE RNS COULDN'T PROCEED TO PRESS START DUE TO AIR DETECTED IN THE LINE. FLOLAN PUMP REPLACED WITH PUMP BROUGHT OVER BY ANOTHER RN. THE PUMP WAS STILL READING AIR DETECTED IN LINE. THEN THE RN PRESSED THE TUBING DEEPER IN THE LEFT SIDE TUBING HOLDER AND THE PROBLEM WAS FIXED. WHILE ALL THIS HAPPENED THE PULMONARY HYPERTENSION (PH) PRESSURE DIDN'T CHANGE. THE PATIENT WAS OFF FLOLAN DRIP FOR APPROXIMATELY 30 MINUTES DUE TO PUMP MALFUNCTION. THE PHYSICIANS WERE MADE AWARE. PULMONARY HYPERTENSION COORDINATOR WAS NOTIFIED OF INCIDENT AND THE CADD-LEGACY PUMP IS OUT OF USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83900 CADD-LEGACY PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC 6400 381813

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR