BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD SOLIS HPCA PUMP

    MDR report key: 21975950 · Received May 7, 2025

    Report

    Report Number
    3012307300-2025-05273
    Event Type
    Malfunction
    Date Received
    May 7, 2025
    Date of Event
    January 24, 2025
    Report Date
    May 7, 2025
    Manufacturer
    SMITH¿S MEDICAL ASD, INC.
    Product Code
    MEA
    PMA / PMN Number
    K170982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FILE WAS ORIGINALLY INCORRECTLY FILED UNDER REGISTRATION NUMBER MRN 2183161-2025-00018. THE DATE OF THAT SUBMISSION WAS 20 FEBRUARY 2025. ONE DEVICE WAS RETURNED FOR ANALYSIS WITH COMPLAINT OF CASSETTE ERROR, NOT LOCKED. LOG EVENTS WAS REVIEWED AND THERE ARE NO ERRORS RELATED TO THE CUSTOMER COMPLAINT. THERE WERE NO SERVICES REPORTED PREVIOUSLY. VISUAL AND FUNCTIONAL TESTING WAS PERFORMED, AND COMPLAINT WAS CONFIRMED. PROBABLE CAUSE WAS FLEX SENSOR CIRCUIT NOT FUNCTIONING PROPERLY. FLEX SENSOR CIRCUIT WAS REPLACED WITH A NEW ONE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD A LOCK CASSETTE ERROR, EVEN THOUGH IT WAS LOCKED. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1871914 CADD SOLIS HPCA PUMP PUMP, INFUSION, PCA MEA SMITH¿S MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown