BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD SOLIS VIP PUMPS - 2120

    MDR report key: 8805240 · Received July 18, 2019

    Report

    Report Number
    3012307300-2019-02934
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Date of Event
    June 10, 2019
    Report Date
    January 29, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    15019517096378
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SMITHS MEDICAL PUMP WAS RETURNED FOR ANALYSIS IN GOOD PHYSICAL CONDITION. THREE SEPARATE DELIVERY ACCURACY TESTS WERE PERFORMED ALL OF WHICH RESULTED IN ACCURACY WITHIN THE PUMP'S DELIVERY ACCURACY MANUFACTURING SPECIFICATIONS. THERE WAS NO FAULT FOUND WITH THE SYSTEM.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT SMITHS MEDICAL CADD SOLIS VIP UNDER DELIVERED MEDICATION. THE PUMP INDICATED THAT THE RESERVOIR VOLUME WAS ZERO. BUT THE HYDRATION BAG WAS MEASURED AND IT WAS FOUND THAT 167 ML WAS REMAINING. THE PUMP CALCULATIONS SHOW THAT 252.3 ML WAS INFUSED BUT THE TOTAL BAG VOLUME IS ONLY 250 ML. THE PUMP FAILED FLUKE TESTING TWICE WITH ACCURACY RESULTS -13.4% AND -11.5%. THE REMAINING CHEMOTHERAPY MEDICATION WAS DELIVERED BY ANOTHER PUMP. THERE WAS NO PATIENT ADVERSE EFFECT DUE TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597052 CADD SOLIS VIP PUMPS - 2120 PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 2120 15019517096378

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR