BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD SOLIS VIP PUMP

    MDR report key: 12259917 · Received August 2, 2021

    Report

    Report Number
    3012307300-2021-07940
    Event Type
    Malfunction
    Date Received
    August 2, 2021
    Date of Event
    July 5, 2021
    Report Date
    February 15, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    15019517150001
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED AFTER DEVICE EVALUATION. H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. A VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED. VISUAL INSPECTION FOUND THE DEVICE INTACT. THE CUSTOMER STATED PROBLEM WAS DUPLICATED. ERROR CODE 41171 APPEARED AT START UP. RELOADED THE SOFTWARE AND THIS CLEARED UP THE PROBLEM. THE CAUSE OF THE REPORTED PROBLEM COULD NOT BE DETERMINED. A DHR REVIEW WAS PERFORMED SUBSEQUENT TO THE MANUFACTURING OF THE DEVICE AND PRIOR TO ITS RELEASE. NO PROBLEMS OR ISSUES WERE IDENTIFIED DURING THIS DHR REVIEW.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT DURING USE OF THIS SMITHS MEDICAL CADD SOLIS VIP PUMP, THE PUMP EXHIBITED ERROR CODE (41171, 4100, 154, 198). NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157915 CADD SOLIS VIP PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 2120 15019517150001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown