BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD SOLIS VIP PUMP

    MDR report key: 20714071 · Received November 18, 2024

    Report

    Report Number
    3012307300-2024-13523
    Event Type
    Malfunction
    Date Received
    November 18, 2024
    Date of Event
    October 1, 2024
    Report Date
    April 9, 2025
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    10610586042829
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A1 - A6, B5 - B7: UPDATED. D3. MANUFACTURING PLANT ADDRESS, CITY, ZIP CODE, STATE, COUNTRY: CORRECTED. H6. INVESTIGATION CODES: UPDATED. INVESTIGATION SUMMARY: THE AFFECTED DEVICE WAS RETURNED FOR EVALUATION. CUSTOMER'S REPORT OF "CASSETTE DETECT ERROR" WAS CONFIRMED IN THE EHL (EVENT HISTORY LOG) WITH MULTIPLE CASSETTES NOT ATTACHED AND OTHER CASSETTE RELATED ALARMS. PERFORMED PRIMING FUNCTION USING 50 ML CASSETTE, UNIT DUPLICATED UPSTREAM OCCLUSION ALARM. THE ROOT CAUSE IS DUE TO WET USO (UPSTREAM OCCLUSION) SENSOR AND FLUID INGRESSION ON DSO (DOWNSTREAM OCCLUSION) SENSOR ASSEMBLY. REPLACED USO SENSOR AND DSO SENSOR ASSEMBLY. UNIT PASSED PRIMING AND ALL FUNCTIONAL TESTS AFTER REPAIR. THE 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

    E1: PHONE EX (B)(6). ONE DEVICE WAS RECEIVED FOR EVALUATION. REVIEW OF THE EVENT HISTORY LOG REVEALED MULTIPLE 'CASSETTE NOT ATTACHED' ALARMS. FUNCTIONAL TESTING WAS ABLE TO DUPLICATE THE REPORTED PROBLEM. THE DOWNSTREAM OCCLUSION SENSOR ASSEMBLY AND UPSTREAM OCCLUSION SENSORS WERE REPLACED. THE DEVICE THEN PASSED ALL FUNCTIONAL TESTS. THE SERVICE HISTORY REVIEW HAD NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE EXHIBITED A CASSETTE DETECT ERROR. THERE WAS UNKNOWN PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2591969 CADD SOLIS VIP PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 2120 10610586042829

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown