BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD SOLIS VIP PUMP

    MDR report key: 8156218 · Received December 12, 2018

    Report

    Report Number
    3012307300-2018-08774
    Event Type
    Malfunction
    Date Received
    December 12, 2018
    Date of Event
    October 25, 2018
    Report Date
    February 5, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    10610586042829
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE CADD SOLIS VIP PUMP WAS RETURNED FOR ANALYSIS. THE DEVICE WAS RECEIVED IN GOOD CONDITION. THE REPORTED PROBLEM REGARDING ERROR CODE "46228" WAS NOT VERIFIED. NO ERROR MESSAGE WAS ALARMED WHEN POWERING UP AND INFUSING THE CUSTOMER'S PUMP. ERROR CODE "46228' WAS FOUND RECORDED IN THE PUMP'S EVENT LOG. CORROSION WAS FOUND ON THE BATTERY TERMINAL AND FLUID INGRESSION WAS FOUND ON THE DOWNSTREAM SENSOR. AS A PREVENTATIVE MEASURE, THE MICRO PROCESSOR BOARD WILL BE REPLACED AND THE PUMP'S BATTERY COMPARTMENT AND DOWNSTREAM SENSOR WILL BE REPLACED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION IN PROGRESS.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT THIS SMITHS MEDICAL CADD SOLIS VIP PUMPS DISPLAYED ERROR CODE LEC 46228. ALSO REPORTED THAT THE PUMP HAD FLUID INGRESSION WITH CORRODED BATTERY TERMINAL. NO REPORTED ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    994746 CADD SOLIS VIP PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 2120 10610586042829

    Patients

    Seq Age Sex Outcome Treatment
    1