BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-LEGACY PLUS AMBULATORY INFUSION PUMP

    MDR report key: 22080702 · Received May 23, 2025

    Report

    Report Number
    3012307300-2025-06126
    Event Type
    Malfunction
    Date Received
    May 23, 2025
    Date of Event
    January 1, 2025
    Report Date
    May 23, 2025
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    B3: UNKNOWN; MONTH AND YEAR VALID E1: PHONE NUMBER PROVIDED IN THE FOLLOWING FORMAT "162188 / (B)(6) NEXT: 35843" H3: ONE PUMP WAS RETURNED FOR ANALYSIS IN USED CONDITION. VISUAL INSPECTION SHOWED THE PUMP WAS IN USED CONDITION. SERVICE HISTORY IDENTIFIED THE COMPLAINT WAS NOT RELATED TO A PREVIOUS SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD. REVIEW OF THE EVENT HISTORY LOG CONFIRMED THE REPORTED ISSUE. FUNCTIONAL TESTING REVEALED THE PUMP WAS ALARMING LOSS OF POWER, INDICATING THAT INFUSION WILL BE STOPPED DUE TO THE ISSUE IF NOT RESOLVED. NO ACTION WAS TAKEN FOR THE REPORTED ISSUE AS THE DEVICE WAS DEEMED BEYOND ECONOMICAL REPAIR. THE PUMP WAS SCRAPPED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP WAS FAULTY AND CONTINUOUSLY BEEPED EVEN WITHOUT BATTERIES. PER REPORTER, THE ISSUE OCCURRED DURING CONTINUOUS MEDICATION ADMINISTRATION. THE PATIENT SUFFERED NO HARM. EVALUATION OF THE RETURNED DEVICE IDENTIFIED THAT THE PUMP WAS ALARMING BATTERY POWER LOSS, INDICATING THE PUMP WAS LOSING POWER DURING INFUSION, AND NOTIFYING MEDICAL STAFF OF THE LOSS OF POWER AND RISK OF INTERRUPTION INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819509 CADD-LEGACY PLUS AMBULATORY INFUSION PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 6500

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown