BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-LEGACY 1 AMBULATORY PUMP

    MDR report key: 13585574 · Received February 23, 2022

    Report

    Report Number
    3012307300-2022-03959
    Event Type
    Malfunction
    Date Received
    February 23, 2022
    Date of Event
    January 6, 2022
    Report Date
    February 23, 2022
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586019548
    PMA / PMN Number
    K982838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED INDICATING BOTH CADD LEGACY 1, MDL 6400, PUMPS WERE EXHIBITING ?NO DISPOSABLE" ERROR. THE END USER HAD BEEN OFF HER IV TREPROSTINIL FOR AT LEAST FIVE HOURS AND NOTED CHANGES IN HER BREATHING. IT WAS REPORTED THE END USER INSISTED ON RESTARTING HERSELF ON HER PREVIOUS DOSE 55 NKM. 34 MU24 HR PUMP RATE, USING 3 ML TREPROSTINIL 5 MG/ML EVERY 48 HOURS DUE TO THE CHANGES IN HER BREATHING.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED INDICATING BOTH CADD LEGACY 1, MDL 6400, PUMPS WERE EXHIBITING ?NO DISPOSABLE" ERROR. THE END USER HAD BEEN OFF HER IV TREPROSTINIL FOR AT LEAST FIVE HOURS AND NOTED CHANGES IN HER BREATHING. IT WAS REPORTED THE END USER INSISTED ON RESTARTING HERSELF ON HER PREVIOUS DOSE 55 NKM. 34 MU24 HR PUMP RATE, USING 3 ML TREPROSTINIL 5 MG/ML EVERY 48 HOURS DUE TO THE CHANGES IN HER BREATHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930542 CADD-LEGACY 1 AMBULATORY PUMP PUMP, INFUSION FRN ST PAUL 6400 10610586019548

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown