BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS VIP AMBULATORY INFUSION PUMP

    MDR report key: 23009643 · Received September 9, 2025

    Report

    Report Number
    3012307300-2025-10477
    Event Type
    Malfunction
    Date Received
    September 9, 2025
    Date of Event
    August 18, 2025
    Report Date
    October 2, 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
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED ONE DEVICE. THE CUSTOMER COMPLAINT OF AIR IN LINE WAS NOT REPLICATED BUT WAS CONFIRMED DURING THE EVENT LOG REVIEW. THE FLAT GEAR AND HUB GEAR WERE OUT OF ALIGNMENT CAUSING THE DUAL FLAG GEAR TO MAKE CONTACT WITH THE CAM SENSOR/OPTIC SENSOR. REPLACED THE DOWNSTREAM OCCLUSION SENSOR (DSO) BEZEL, DSO SEAL, OPTIC SWITCH, OPTIC SWITCH BRACKET, MOTOR, FLAT GEAR, HUB GEAR, DUAL FAG GEAR, EXPULSOR FOAM, SMALL BEARING, LARGE BEARING, GASKET 1, GASKET 2, CAM SHAFT, FLAG DISK RETAINER, KEYPAD, OVERLAY, SIDE LABEL, AND REAR LABEL. PERFORMED SENSOR CALIBRATION. PERFORMED PERFORMANCE VERIFICATION TESTS (PVT) , UNIT PASS ALL TESTING CRITERIA. SOFTWARE UPDATED. UNIT RESET TO STANDARD CONFIGURATION. SERVICE HISTORY REVIEW IDENTIFIED THERE WAS NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AIR IN-LINE ERROR. THE EVENT OCCURRED DURING TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2824659 CADD-SOLIS VIP AMBULATORY INFUSION PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 15019517150001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown