BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS VIP AMBULATORY INFUSION PUMP

    MDR report key: 21426848 · Received February 20, 2025

    Report

    Report Number
    3012307300-2025-02091
    Event Type
    Malfunction
    Date Received
    February 20, 2025
    Date of Event
    November 1, 2024
    Report Date
    February 20, 2025
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FILE WAS ORIGINALLY INCORRECTLY FILED UNDER REGISTRATION NUMBER MRN 2183161-2025-00016. THE DATE OF THAT SUBMISSION WAS 2/20/2025.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD A WHITE SCREEN ISSUE AND NOTHING WAS DISPLAYING. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1095343 CADD-SOLIS VIP AMBULATORY INFUSION PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 2120

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown