BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CADD

    MDR report key: 834076 · Received March 28, 2007

    Report

    Report Number
    MW1042424
    Event Type
    Injury
    Date Received
    March 28, 2007
    Date of Event
    January 19, 2007
    Report Date
    March 13, 2007
    Manufacturer
    SMITH'S MEDICAL
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WITH CVL - ON CONTINUOUS INFUSION OF FLOLAN VIA ELECTRONIC INFUSION PUMP. EXPERIENCED HI PRESSURE ALARMS - SOUGHT MEDICAL ATTENTION - CVL NOT PATENT. LINE REMOVED - PERIPHERAL ACCESS ESTABLISHED AND CVL REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CADD CADD LEGACY CASSETTES FPA SMITH'S MEDICAL * ALL ENDING IN X-16

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R