BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD SOLIS VIP PUMP

    MDR report key: 21836445 · Received April 14, 2025

    Report

    Report Number
    3012307300-2025-04236
    Event Type
    Malfunction
    Date Received
    April 14, 2025
    Date of Event
    March 17, 2025
    Report Date
    June 20, 2025
    Manufacturer
    SMITHS MEDICAL ASD, INC
    Product Code
    FRN
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    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 ROOT CAUSE WAS UNABLE TO BE ESTABLISHED. THE SERVICE HISTORY REVIEW HAD NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP HAD ALARMED AND HAD STOPPED WITHOUT WARNING APPROXIMATELY 24 HOURS INTO PATIENT'S TREATMENT. THE PATIENT HAD BEEN REQUIRED TO MAKE A TRIP TO LCI UNION TO HAVE THE ISSUE RESOLVED. IT HAD BEEN STATED THAT THE NURSE AT UNION HAD UNLOCKED THE PUMP, REMOVED THE CARTRIDGE, RECONNECTED IT, AND RESTARTED THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127438 CADD SOLIS VIP PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC 2120

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown