BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS VIP AMBULATORY INFUSION PUMP

    MDR report key: 17905834 · Received October 10, 2023

    Report

    Report Number
    3012307300-2023-09578
    Event Type
    Malfunction
    Date Received
    October 10, 2023
    Date of Event
    August 31, 2023
    Report Date
    January 26, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    15019517150001
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: ADDITIONAL CONTACT INFORMATION: UC (B)(6) MEDICAL CENTER, (B)(6). INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED. WE ARE UNABLE TO CONFIRM THE REPORTED COMPLAINT. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION. THE MOST PROBABLE CAUSE IS THE MAIN BOARD; HOWEVER, THIS CANNOT BE CONFIRMED AS NO PRODUCT WAS RETURNED FOR INVESTIGATION. THE SERVICE HISTORY REVIEW IDENTIFIED NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD. D3, G1,G2 EMAIL IS:(B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP WAS ALARMING WITH A BLANK SCREEN. PER REPORTER THE PUMP WAS POWERED ON AND IT ALARMED THE CASSETTE WAS PARTIALLY ATTACHED. TROUBLESHOOTING WAS ATTEMPTED AND IT WAS REPORTED THAT WHEN THE CASSETTE WAS REPLACED THE PUMP ALARMED THAT PUMP DATA AND PATIENT SETTINGS WERE LOST. NO ADVERSE PATIENT EFFECTS WERE REPORTED. PER REPORTER NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282541 CADD-SOLIS VIP AMBULATORY INFUSION PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 2120 15019517150001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown