BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP KIT, CADD-SOLIS VIP

    MDR report key: 19524204 · Received June 12, 2024

    Report

    Report Number
    3012307300-2024-04891
    Event Type
    Malfunction
    Date Received
    June 12, 2024
    Date of Event
    May 1, 2024
    Report Date
    July 24, 2024
    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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: D4 ¿ UDI. ONE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION FOUND TWO MISSING SEPARATORS, A SCRATCHED LCD LENS, WORN DSO SEAL, AND USO SEAL. A SYSTEM FAULT 44,510 ERROR WAS REVEALED TWICE IN THE EVENT HISTORY LOG. FUNCTIONAL TESTING WAS ABLE TO DUPLICATE THE REPORTED PROBLEM. IT WAS DETERMINED THAT THE CAUSE REGARDING EC 44,510 WAS USER INTERFACE IRQ ABORT. THE ISSUE RELATED TO REAL TIME CLOCK BATTERY DEPLETED. TO ADDRESS THE ISSUE, THE SOFTWARE WAS UPGRADED. THE SERVICE HISTORY REVIEW HAD NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD.

    Additional Manufacturer Narrative · 0

    B3 IS UNKNOWN. A SUPPLEMENT 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 DEVICE REQUIRES A SOFTWARE UPGRADE. THE LAST ERROR CODE WAS 44510. THE DEVICE HAD A SCRATCHED LENS AND MISSING BATTERY STABILIZERS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182683 PUMP KIT, CADD-SOLIS VIP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC 2120 15019517150001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown