BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS HPCA PUMP

    MDR report key: 20196356 · Received September 11, 2024

    Report

    Report Number
    3012307300-2024-08934
    Event Type
    Malfunction
    Date Received
    September 11, 2024
    Date of Event
    December 1, 2023
    Report Date
    September 11, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC
    Product Code
    MEA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3 UNKNOWN. ONE DEVICE WAS RETURNED FOR REPAIR IN GOOD CONDITION. THIS DEVICE HAS NOT BEEN SERVICED IN THE PAST. FUNCTIONAL TEST FOUND ERROR CODE 46515 AND THE PRIMARY PROBLEM WAS REPLICATED. THE CAUSE OF THE PROBLEM WAS IU ERROR IRQ OS INT NESTING. DEVICE NEEDS TO RECHARGE FOR 250 HOURS AND PERFORM STANDARD PREVENTATIVE MAINTENANCE TO CORRECT THE ISSUE. THE DEVICE PASSED ALL FUNCTIONAL TESTS AFTER THE REPAIR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ERROR CODE 46515. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1593644 CADD-SOLIS HPCA PUMP PUMP, INFUSION, PCA MEA SMITHS MEDICAL ASD, INC 2110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown