BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS AMBULATORY INFUSION PUMP

    MDR report key: 20126811 · Received September 3, 2024

    Report

    Report Number
    3012307300-2024-08479
    Event Type
    Malfunction
    Date Received
    September 3, 2024
    Date of Event
    July 1, 2024
    Report Date
    November 14, 2024
    Manufacturer
    MEA
    Product Code
    MEA
    UDI-DI
    10610586038808
    PMA / PMN Number
    K130394
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ONE DEVICE WAS RETURNED FOR REPAIR. REVIEW OF EVENT LOG FOUND NO CASSETTE ATTACH ERROR. THERE WAS NO RELEVANT SERVICE HISTORY. VISUAL AND FUNCTIONAL TESTS WERE PERFORMED. CONFIRMED CUSTOMER COMPLAINT ¿ATTACH/REATTACH ERROR¿. DEVICE ERRORS WHEN A CASSETTE IS ATTACHED. DURING VERIFICATION INSPECTION, IT WAS FOUND THE DOWNSTREAM OCCLUSION (DSO) SENSOR IS BAD AND BEZEL SEAL. NOTED THE AIR DETECTOR WAS LOOSE. NOTED LIQUID RESIDUE ON INTERNAL COMPONENTS OF THE CHASSIS. NOTED AC PORT NO LONGER POWERS UNIT. REPLACED THE DSO SENSOR AND BEZEL SEAL AS WELL AS THE AIR DETECTOR. REPLACED CHASSIS GASKETS. REPLACED MAIN BOARD. DEVICE PASSED SELF-CHECK AND CASSETTE VERIFICATION TESTING.

    Additional Manufacturer Narrative · 0

    B3: UNKNOWN; EXACT DATE UNKNOWN. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD AN ATTACH/REATTACH ERROR. THERE WAS UNKNOWN PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1342110 CADD-SOLIS AMBULATORY INFUSION PUMP PUMP, INFUSION, PCA MEA MEA 2110 10610586038808

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown