BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS VIP AMBULATORY INFUSION PUMP

    MDR report key: 21245550 · Received January 27, 2025

    Report

    Report Number
    3012307300-2025-01189
    Event Type
    Malfunction
    Date Received
    January 27, 2025
    Date of Event
    January 1, 2025
    Report Date
    January 27, 2025
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    15019517126587
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    B3: UNKNOWN; NO INFORMATION HAS BEEN PROVIDED TO DATE. H3: THE DEVICE WAS RECEIVED FOR EVALUATION. SERVICE HISTORY REVIEW IDENTIFIED THERE WAS NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD. THE EVENT HISTORY WAS REVIEWED. VISUAL AND FUNCTIONAL TESTS WERE PERFORMED, AND THE DOWNSTREAM OCCLUSION (DSO) SEAL WAS FOUND TO BE DELAMINATED. IT WAS ALSO FOUND THAT THE MOTOR ODO WAS AT 8910830 AND OUT OF SPECIFICATION. THE DSO SEAL AND MOTOR WERE REPLACED TO FIX THE ISSUE.

    Description of Event or Problem · 0

    THE RESULT OF THE INVESTIGATION FOUND THAT THE DEVICE HAD A DELAMINATED DOWNSTREAM OCCLUSION (DSO) SEAL. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606492 CADD-SOLIS VIP AMBULATORY INFUSION PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 2120 15019517126587

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown