BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS VIP AMBULATORY INFUSION PUMP

    MDR report key: 19707438 · Received July 9, 2024

    Report

    Report Number
    3012307300-2024-05926
    Event Type
    Malfunction
    Date Received
    July 9, 2024
    Date of Event
    June 1, 2024
    Report Date
    July 9, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC
    Product Code
    FRN
    UDI-DI
    106105860428299
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: UNKNOWN; NO INFORMATION HAS BEEN PROVIDED TO DATE. THE DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION NOTED THAT THE DOWNSTREAM OCCLUSION (DSO) SEAL WAS DEGRADED, AND THE LCD LENS WERE SCRATCHED. FUNCTIONAL TESTING AND VISUAL TESTS WERE CONDUCTED WITH THE RETURNED DEVICE. THE CUSTOMER PROBLEM WAS NOT DUPLICATED. THE ROOT CAUSE OF THE PROBLEM WAS CONTAMINATION. THE SERVICE HISTORY REVIEW IDENTIFIED THERE WAS NO INDICATION THE COMPLAINT WAS RELATED TO PREVIOUS SERVICE OF THE DEVICE. AS A PREVENTATIVE MEASURE, THE DSO SENSOR WAS REPLACED TO CORRECT THE ISSUE. THE BEZEL, SEAL, LCD LENS AND LABELS WERE ALSO REPLACED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE EXHIBITED CASSETTE IS NOT ATTACHING PROPERLY AND THERE WAS A BUBBLE ON THE BOTTOM. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED. ANALYSIS REVEALED THAT THE DOWNSTREAM OCCLUSION SEAL WAS DEGRADED, AND THE LCD SCREEN WAS SCRATCHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545639 CADD-SOLIS VIP AMBULATORY INFUSION PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC 2120 106105860428299

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown