BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS VIP AMBULATORY INFUSION PUMP

    MDR report key: 21427146 · Received February 20, 2025

    Report

    Report Number
    3012307300-2025-02092
    Event Type
    Malfunction
    Date Received
    February 20, 2025
    Date of Event
    January 1, 2025
    Report Date
    June 24, 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
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FILE WAS ORIGINALLY INCORRECTLY FILED UNDER REGISTRATION NUMBER MRN 2183161-2025-00030. THE DATE OF THAT SUBMISSION WAS 2/20/2025.

    Additional Manufacturer Narrative · 0

    ONE DEVICE WAS RECEIVED. DURING THE VISUAL INSPECTION, THE UPSTREAM OCCLUSION (USO) SEAL WAS FOUND TO BE SEPARATING FROM THE CHASSIS. DURING THE FUNCTIONAL TESTING, THE CUSTOMER REPORTED COMPLAINT WAS CONFIRMED. THE DEVICE CONSTANTLY DETECTS AIR. THE AIR IN LINE DETECTOR WAS REPLACED. THE UNIT PASSED ALL TESTING CRITERIA. 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 "AIR IN LINE DEFECTIVE". THE EVENT OCCURRED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037417 CADD-SOLIS VIP AMBULATORY INFUSION PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 2120 15019517150001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown