BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD SOLIS VIP

    MDR report key: 14541341 · Received May 30, 2022

    Report

    Report Number
    3012307300-2022-10030
    Event Type
    Malfunction
    Date Received
    May 30, 2022
    Report Date
    May 30, 2022
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586042829
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO SMITHS/ICU MEDICAL. THE CUSTOMER'S REPORTED PROBLEM OF "WON'T TURN OFF/LOSS IT PROGRAM MEMORY" WAS NOT DUPLICATED IN THE PUMP, DURING INVESTIGATION. HOWEVER, PUMP SETTINGS AND PATIENT DATA LOST WERE FOUND IN THE PUMP'S EVENT HISTORY LOG. CONNECTED AN AC POWER, AND CHARGED THE DEVICE FOR THREE DAYS, SOLVING THE ISSUE. 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 1223199: IT WAS REPORTED THAT THE PUMP WON'T TURN OFF. IT LOST IT PROGRAM MEMORY. ADDITIONAL INFORMATION RECEIVED BY SMITHS MEDICAL/ICU ON (B)(6) 2022 VIA EMAIL AND ATTACHED TO COMPLAINT OBJECT: THIS WAS DISCOVERED WHILE IN-HOUSE TESTING, NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2713429 CADD SOLIS VIP PUMP, INFUSION FRN ST PAUL 2120 10610586042829

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown