BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS HCPA PUMP

    MDR report key: 19711131 · Received July 10, 2024

    Report

    Report Number
    3012307300-2024-05936
    Event Type
    Malfunction
    Date Received
    July 10, 2024
    Date of Event
    May 1, 2024
    Report Date
    July 10, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC
    Product Code
    MEA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) B3: UNKNOWN; NO INFORMATION HAS BEEN PROVIDED TO DATE. THE DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION NOTED THAT THE DOWNSTREAM OCCLUSION (DSO) SEAL WAS DEGRADED, AND THE LCD LENS WAS SCRATCHED. NO ISSUES WERE FOUND IN THE EVENT HISTORY LOG. FUNCTIONAL TESTING WAS PERFORMED, AND THE CUSTOMER PROBLEM WAS DUPLICATED. THE ROOT CAUSE OF THE PROBLEM WAS RDC PIN BROKEN AND STUCK INSIDE THE REMOTE DOSE JACK OF THE MAINBOARD. THE SERVICE HISTORY REVIEW IDENTIFIED THERE WAS NO INDICATION THE COMPLAINT WAS RELATED TO PREVIOUS SERVICE OF THE DEVICE. AS A RESULT, THE MAIN BOARD WAS REPLACED. THE LCD DISPLAY, DSO SENSOR, BEZEL, SEAL, LCD LENS AND LABELS WERE ALSO REPLACED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A REMOTE DOSE PIN WAS STUCK INSIDE THE REMOTE DOSE JACK. THERE WAS NO PATIENT INVOLVEMENT. ANALYSIS IDENTIFIED THAT THE DOWNSTREAM OCCLUSION (DSO) SEAL WAS DEGRADED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363012 CADD-SOLIS HCPA PUMP PUMP, INFUSION, PCA MEA SMITHS MEDICAL ASD, INC 2110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown