BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD SOLIS VIP AMBULATORY INFUSION PUMP

    MDR report key: 19530268 · Received June 13, 2024

    Report

    Report Number
    3012307300-2024-04960
    Event Type
    Malfunction
    Date Received
    June 13, 2024
    Date of Event
    May 1, 2024
    Report Date
    August 7, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    15019517096378
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: A CODE A08 (CALIBRATION PROBLEM) CORRECTED TO A140505 (INACCURATE FLOW RATE) TO REFLECT MEDICAL DEVICE PROBLEM ALLEGATION "FAILED RATE ACCURACY TEST." THE DEVICE WAS RETURNED FOR ROOT CAUSE ANALYSIS AND THE INVESTIGATION FINDINGS CONCLUDED AFTER A VISUAL INSPECTION, FUNCTIONAL TESTING, ACCURACY TESTING, AND EVENT HISTORY LOG (EHL) REVIEW, THE CUSTOMER PROBLEM WAS DUPLICATED. THE PUMP FAILED THREE CONSECUTIVE TIMES WHEN PERFORMING ACCURACY TEST, AND THE CAUSE OF THE CUSTOMER REPORTED PROBLEM WAS AN OUT OF SPECIFICATION EXPULSOR. SERVICE HISTORY REVIEW IDENTIFIED THERE WAS NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD. THE MANUFACTURER REPRESENTATIVE REPLACED THE EXPULSOR TO CORRECT THE REPORTED PROBLEM, AND THE PUMP PASSED ALL FUNCTIONAL TESTS AND PERFORMED AS INTENDED AFTER REPAIR.

    Additional Manufacturer Narrative · 0

    B3: UNKNOWN. H3: DEVICE NOT RECEIVED BY MANUFACTURER. 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 THE DEVICE WAS OUT OF CALIBRATION. FAILED RATE ACCURACY TEST. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803484 CADD SOLIS VIP AMBULATORY INFUSION PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 2120 15019517096378

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown