BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS VIP AMBULATORY INFUSION PUMP

    MDR report key: 21426807 · Received February 20, 2025

    Report

    Report Number
    3012307300-2025-02090
    Event Type
    Malfunction
    Date Received
    February 20, 2025
    Date of Event
    November 1, 2024
    Report Date
    June 9, 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 2183161-2025-00015. THE DATE OF THAT SUBMISSION WAS 2/20/2025.

    Additional Manufacturer Narrative · 0

    ONE DEVICE WAS RECEIVED FOR INVESTIGATION. THE REPORTED ISSUE WAS CONFIRMED DURING FUNCTIONAL TESTING WHEN THE REPORTED ISSUE WAS DUPLICATED. THE ISSUE WAS TRACED TO THE DEVICE DOWNSTREAM OCCLUSION SENSOR. THE PRODUCT'S HISTORY RECORDS WERE REVIEWED AND THERE WERE NO NON-CONFORMANCES NOR SERVICE-RELATED ISSUES THAT WOULD HAVE RESULTED IN THE REPORTED COMPLAINT. THE DEVICE DOWNSTREAM OCCLUSION SEAL WAS REPLACED AND THE DEVICE PASSED ALL TESTING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP HAD A CASSETTE ATTACHED ERROR. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465802 CADD-SOLIS VIP AMBULATORY INFUSION PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 2120

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown