BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD SOLIS PUMP KIT

    MDR report key: 14541353 · Received May 30, 2022

    Report

    Report Number
    3012307300-2022-10031
    Event Type
    Malfunction
    Date Received
    May 30, 2022
    Report Date
    July 26, 2022
    Manufacturer
    ST PAUL
    Product Code
    MEA
    PMA / PMN Number
    K170982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO SMITHS/ICU MEDICAL.

    Additional Manufacturer Narrative · 0

    H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. A VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED. VISUAL INSPECTION FOUND THE DEVICE IN GOOD CONDITION. THE CUSTOMER STATED PROBLEM WAS DUPLICATED. RUNNING THREE ACCURACY TESTS, THE PUMP WAS FOUND TO BE OVER DELIVERING TO THE MANUFACTURING SPECIFICATIONS. REPLACED EXPULSOR DUE TO OVER-DELIVERY. THE CAUSE OF THE REPORTED PROBLEM COULD NOT BE DETERMINED. A MANUFACTURING DHR REVIEW WAS NOT PERFORMED BECAUSE THE RESULTS OF THE COMPLAINT INVESTIGATION DO NOT INDICATE A PROBLEM WITH THE MANUFACTURE OR LAST REPAIR OF THE DEVICE. NO MANUFACTURING OR SERVICE ISSUES WERE IDENTIFIED AS CAUSES OF THE CUSTOMER'S REPORTED PROBLEM DURING THE REVIEW OF SERVICE AND REPAIR RECORDS. THEREFORE, NO MANUFACTURING OR SERVICE RECORDS REVIEW IS NEEDED.

    Description of Event or Problem · 0

    ORACLE RO 1230428: IT WAS REPORTED THAT THE PUMP FAILED AN ACCURACY TEST. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2714513 CADD SOLIS PUMP KIT PUMP, INFUSION MEA ST PAUL 2110

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown