BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD SOLIS HPCA AMBULATORY INFUSION PUMP

    MDR report key: 21004927 · Received December 23, 2024

    Report

    Report Number
    3012307300-2024-15376
    Event Type
    Malfunction
    Date Received
    December 23, 2024
    Date of Event
    November 1, 2024
    Report Date
    April 1, 2025
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    MEA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    D3. MANUFACTURING PLANT ADDRESS, CITY, ZIP CODE, STATE, COUNTRY: CORRECTED. H6. INVESTIGATION CODES: UPDATED. INVESTIGATION SUMMARY: THE INITIAL CUSTOMER REPORT INDICATES AN ISSUE WITH CONTINUOUS ALARM. THE ALARM WAS REPLICATED BY 41622 ERROR_MOTOR_TIMEOUT. DURING THE REPAIR IT WAS FOUND THAT THE MOTOR CAM SENSOR WAS DAMAGED, IT WAS REPLACED WITH A NEW ONE. IT WAS ALSO FOUND THAT THE LCD CONNECTOR WAS DAMAGED, AND NOT HAVING A SPARE PART OF THAT VERSION, IT WAS DECIDED TO CHANGE THE MAIN BOARD COMPLETELY AND LCD. THE SOFTWARE WAS UPDATED TO 97-0582-040301-01. THE PERFORMANCE VERIFICATION TEST WAS PERFORMED. ALL TESTS PASSED WITHIN SPECIFICATIONS. PROBABLE CAUSE: 41622 ERROR_MOTOR_TIMEOUT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE EXHIBITED ERROR CODE 41622-1003. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2628893 CADD SOLIS HPCA AMBULATORY INFUSION PUMP PUMP, INFUSION, PCA MEA SMITHS MEDICAL ASD, INC. 2110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown