BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS AMBULATORY INFUSION PUMP

    MDR report key: 19442308 · Received June 1, 2024

    Report

    Report Number
    3012307300-2024-04471
    Event Type
    Malfunction
    Date Received
    June 1, 2024
    Date of Event
    May 1, 2024
    Report Date
    May 31, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    MEA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3. DATE OF EVENT: UNKNOWN. NO INFORMATION HAS BEEN PROVIDED TO DATE. INVESTIGATION SUMMARY RECEIVED CADD-SOLIS AMBULATORY INFUSION PUMP SN: 1301875. A VISUAL AND FUNCTIONAL EVALUATION REVEALED NO DAMAGE OR MALFUNCTION. THE EHL WAS REVIEWED. THE CUSTOMER REPORTED PROBLEM COULD NOT BE DUPLICATED. CASSETTE LOCK WORKING, AND NO ERROR MESSAGE FOUND. SERVICE HISTORY REVIEW IDENTIFIED THIS DEVICE HAS NOT BEEN IN FOR SERVICE PREVIOUSLY. AS A PREVENTIVE MEASURE THE DSO SENSOR AND LATCH/LOCK FLEX SENSOR WERE REPLACED.

    Description of Event or Problem · 0

    IT WAS STATED THAT THE PUMP WAS GIVING AN ERROR MESSAGE¿ CASSETTE NOT LOCKED¿. EVEN THOUGH THE CASSETTE IS LOCKED, THE PUMP CONTINUED TO GIVE THIS ERROR MESSAGE 240502-002693. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265155 CADD-SOLIS AMBULATORY INFUSION PUMP PUMP, INFUSION, PCA MEA SMITHS MEDICAL ASD, INC. 2110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown