BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-LEGACY PLUS PUMP

    MDR report key: 13315748 · Received January 21, 2022

    Report

    Report Number
    3012307300-2022-01387
    Event Type
    Malfunction
    Date Received
    January 21, 2022
    Report Date
    January 21, 2022
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586019647
    PMA / PMN Number
    K982836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED AND VISUAL INSPECTION REVEALED HOUSING INTACT, SCREEN SCRATCHED. THE REPORTED EVENT WAS CONFIRMED. A DHR REVIEW WAS PERFORMED SUBSEQUENT TO THE MANUFACTURING OF THE DEVICE AND PRIOR TO ITS RELEASE. NO PROBLEMS OR ISSUES WERE IDENTIFIED DURING THIS DHR REVIEW. THE DEVICE WAS POWERED UP AND ALARMED EC(B)(4) WHICH IS A CORRUPTION OF THE MEMORY OF THE CIRCUIT BOARD. REPLACED CIRCUIT BOARD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT (B)(6) PUMP DISPLAYED ERROR CODE DURING TESTING. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729865 CADD-LEGACY PLUS PUMP PUMP, INFUSION FRN ST PAUL 6500 10610586019647

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown