BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD SOLIS VIP PUMP

    MDR report key: 14625706 · Received June 7, 2022

    Report

    Report Number
    3012307300-2022-11002
    Event Type
    Malfunction
    Date Received
    June 7, 2022
    Report Date
    October 28, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    15019517096378
    PMA / PMN Number
    K111275
    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

    OTHER TEXT: D5: OPERATOR OF DEVICE: UNKNOWN. E4: INITIAL REPORTER ALSO SENT REPORT TO FDA?: UNKNOWN. H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED. H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED. VISUAL INSPECTION FOUND CONTAMINATION ON THE CHASSIS/DOWNSTREAM OCCLUSION SENSOR. THE EVENT LOG HISTORY WAS REVIEWED AND EVIDENCE OF ERROR MESSAGES WAS FOUND. UPON FUNCTION TESTING, THE REPORTED PROBLEM WAS DUPLICATED. FLUID INGRESSION WAS IDENTIFIED ON THE DOWNSTREAM OCCLUSION SENSOR. THE ROOT CAUSE IS UNKNOWN. THE SENSOR WAS REPLACED TO RESOLVE THE ISSUE. MANUFACTURING DEVICE HISTORY RECORD REVIEW WAS NOT PERFORMED BECAUSE THE RESULTS OF THE COMPLAINT INVESTIGATION DO NOT INDICATE A PROBLEM WITH THE MANUFACTURE OF THE DEVICE. NO CAUSES OR POTENTIAL CAUSES OF THE CUSTOMER'S REPORTED PROBLEM WERE FOUND DURING THE REVIEW OF SERVICE AND REPAIR RECORDS.

    Description of Event or Problem · 0

    ORACLE RO 1233137: IT WAS REPORTED THAT THE CASSETTE WAS NOT ATTACHED PROPERLY. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1320440 CADD SOLIS VIP PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 2120 15019517096378

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown