BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY PLUS PUMP

    MDR report key: 14631996 · Received June 8, 2022

    Report

    Report Number
    3012307300-2022-11105
    Event Type
    Malfunction
    Date Received
    June 8, 2022
    Report Date
    August 26, 2022
    Manufacturer
    ST PAUL
    Product Code
    FRN
    PMA / PMN Number
    K982836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION OF THE RETURNED DEVICE COULD NOT CONFIRM THE CUSTOMER REPORTED ISSUE. POSSIBLE DEFECTIVE DOWNSTREAM SENSOR COULD BE THE CAUSE OF THE REPORTED PROBLEM. A MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT PERFORMED BECAUSE THE RESULTS OF THE COMPLAINT INVESTIGATION DO NOT INDICATE A PROBLEM WITH THE MANUFACTURE OF THE DEVICE. NO CAUSES OR POTENTIAL CAUSES OF THE CUSTOMER'S REPORTED PROBLEM WERE FOUND DURING THE REVIEW OF SERVICE AND REPAIR RECORDS. THE DEVICE WAS MANUFACTURED JUN. 2020, AND IS OUT OF WARRANTY THEREFORE, NO MANUFACTURING DHR REVIEW IS NEEDED. OPERATOR OF DEVICE IS PATIENT/CONSUMER.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: H6: EVENT PROBLEM AND EVALUATION CODES: UPDATES NOT REQUIRED., CORRECTED DATA: D4: CORRECTION: CATALOG NUMBER: 21-6500-09. D4: CORRECTION: MODEL NUMBER: 6500.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE IS SHOWING NO DISPOSABLE PUMP WON'T RUN ALARM. ISSUE WAS RESOLVED THROUGH TROUBLESHOOTING AND PATIENT EDUCATION. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2217815 CADD LEGACY PLUS PUMP PUMP, INFUSION FRN ST PAUL 6500

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown