BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD SOLIS HPCA PUMP

    MDR report key: 20233892 · Received September 17, 2024

    Report

    Report Number
    3012307300-2024-09310
    Event Type
    Malfunction
    Date Received
    September 17, 2024
    Date of Event
    August 1, 2024
    Report Date
    November 14, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    MEA
    UDI-DI
    10610586038778
    PMA / PMN Number
    K130394
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: ONE DEVICE WAS RETURNED FOR REPAIR WITH COMPLAINT OF CASSETTE NOT ATTACHED PROPERLY. NO PREVIOUS REPAIR ORDERS WERE FOUND. CONFIRMED ¿CASSETTE NOT ATTACHED PROPERLY¿ COMPLAINT BY REVIEWING THE EVENT LOG, DOWNSTREAM OCCLUSION (DSO) CALIBRATION TEST, DSO PRESSURE TEST, AND CHECKING THE MV IN THE MAIN MENU A/D SCREEN. DEVICE FAILED INITIAL TESTING WITH CASSETTE NOT ATTACHED ALARM. REPLACED THE DSO SENSOR AND RETESTED WITH A PSI 20.17 AND DEVICE PASSED. ALL TESTS PASSED AND THE ALARM IS NO LONGER PRESENT IN THE EVENT LOG. PROBABLE CAUSE OF THE COMPLAINT WAS DSO SENSOR FAILURE.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE EXHIBITED AN "ATTACH AND RE-ATTACH CASSETTE" ERROR. THE EVENT OCCURRED DURING SELF-TEST. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2531300 CADD SOLIS HPCA PUMP PUMP, INFUISON, PCA MEA SMITHS MEDICAL ASD, INC. 2110 10610586038778

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown