BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS VIP AMBULATORY INFUSION PUMP

    MDR report key: 19619186 · Received June 26, 2024

    Report

    Report Number
    3012307300-2024-05516
    Event Type
    Malfunction
    Date Received
    June 26, 2024
    Date of Event
    May 1, 2024
    Report Date
    June 26, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    10610586042829
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: UNKNOWN EVENT DATE; NO INFORMATION HAS BEEN PROVIDED TO DATE. THE DEVICE WAS RETURNED FOR ROOT CAUSE ANALYSIS AND THE INVESTIGATION FINDINGS CONCLUDED AFTER A VISUAL INSPECTION AND FUNCTIONAL TESTING, AND DOWNLOADING THE EVENT HISTORY LOGS (EHL), THE PUMP DUPLICATED ERROR 41541/2003 WITH A RED SCREEN WHEN PRIMING 10 ML FUNCTION. THE MANUFACTURER REPRESENTATIVE FOUND THE ALARM VERIFIED ON THE EHL, AND A FAULTY MAIN BOARD WAS THE CAUSE. THE CUSTOMER PROBLEM WAS DUPLICATED. SERVICE HISTORY REVIEW IDENTIFIED THE DEVICE WAS LAST SERVICED IN AUGUST 2023 AND THE COMPLAINT WAS RELATED TO THAT PREVIOUS REPAIR. THE MANUFACTURER REPRESENTATIVE REPLACED THE MAIN BOARD, LENS, LENS GASKET, AND THE KEYPAD. THE PUMP PASSED ALL FUNCTIONAL TESTS AFTER THE REPLACEMENTS AND PERFORMED AS INTENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ERROR CODE 41541/2003 240528-001094. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN HARM/ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688890 CADD-SOLIS VIP AMBULATORY INFUSION PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 2120 10610586042829

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown