BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS VIP AMBULATORY INFUSION PUMP

    MDR report key: 20515990 · Received October 23, 2024

    Report

    Report Number
    3012307300-2024-11861
    Event Type
    Malfunction
    Date Received
    October 23, 2024
    Date of Event
    September 25, 2024
    Report Date
    January 7, 2025
    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

    E1-REPORTER FACILITY NAME: (B)(6). H3: 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 REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO DEVICE WAS RECEIVED; THEREFORE, VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE REPORTED ISSUE COULD NOT BE CONFIRMED. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION. THE SERVICE HISTORY REVIEW IDENTIFIED THERE WAS NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE EXHIBITED AN AIR-IN-LINE ALARM. PER REPORTER, THE PATIENT WAS INSTRUCTED TO CLAMP THE INTRAVENOUS (IV) TUBING AND CHECK THE LOCKED SILVER BAR THEN WAS ADVISED TO TAP THE SIDE OF THE PUMP ON THEIR PALM FIVE TIMES AND RESTART IT. DESPITE THESE STEPS, THE AIR-IN-LINE ALARM PERSISTED, SO THE PROCESS WAS REPEATED. WHEN THE ALARM CONTINUED, THE PUMP WAS POWERED OFF, AND THE SFI WAS FOLLOWED. THE PATIENT WAS INSTRUCTED TO CALL THE FACILITY FOR FURTHER HELP. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT AT THE PATIENT'S HOME. THERE WAS A PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294659 CADD-SOLIS VIP AMBULATORY INFUSION PUMP PUMP,INFUSION FRN SMITHS MEDICAL ASD, INC 2120 15019517150001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 5FU.