BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD SOLIS VIP PUMP

    MDR report key: 14541326 · Received May 30, 2022

    Report

    Report Number
    3012307300-2022-10028
    Event Type
    Malfunction
    Date Received
    May 30, 2022
    Report Date
    May 30, 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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO SMITHS/ICU MEDICAL. AFTER RUNNING THREE ACCURACY TESTS, THE PUMP WAS FOUND TO BE UNDER DELIVERING TO THE MANUFACTURING SPECIFICATIONS. THE EXPULSOR ASSEMBLY WAS REPLACED. A MANUFACTURING DHR REVIEW WAS NOT PERFORMED BECAUSE THE RESULTS OF THE COMPLAINT INVESTIGATION DO NOT INDICATE A PROBLEM WITH THE MANUFACTURE OF THE DEVICE. NO MANUFACTURING RELATED CAUSES OR POTENTIAL CAUSES OF THE CUSTOMER'S REPORTED PROBLEM WERE FOUND DURING THE REVIEW OF SERVICE AND REPAIR RECORDS. THEREFORE, NO MANUFACTURING DHR REVIEW IS NEEDED.

    Description of Event or Problem · 0

    ORACLE RO 1221926: A LOW FLOW RATE ((B)(4)) WAS REPORTED (DURING TESTING). NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2679231 CADD SOLIS VIP PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 2120 15019517150001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown