BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS HCPA PUMP

    MDR report key: 19690571 · Received July 8, 2024

    Report

    Report Number
    3012307300-2024-05841
    Event Type
    Malfunction
    Date Received
    July 8, 2024
    Date of Event
    June 1, 2024
    Report Date
    August 21, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    MEA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    B3: UNKNOWN; NO INFORMATION HAS BEEN PROVIDED TO DATE. E1: FACILITY NAME (B)(6). ADDRESS LINE 2 "SMITHS MEDICAL JAPAN CO., LTD. METROPOLITAN REGION" PHONE NUMBER "(B)(6). 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.

    Additional Manufacturer Narrative · 0

    ONE PUMP WAS RETURNED FOR ANALYSIS IN USED CONDITION. VISUAL INSPECTION FOUND THE DEVICE WAS IN GOOD CONDITION. SERVICE HISTORY REVIEW IDENTIFIED NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE VIEW PERIOD. AS A RESULT OF CHECKING THE EVENT HISTORY LOG, IT WAS CONFIRMED THAT THERE WAS A RECORD OF THE OCCLUSION ALARM OCCURRING DURING PUMP OPERATION. FUNCTIONAL TESTING COULD NOT CONFIRM THE CUSTOMER REPORTED ISSUE. THE INVESTIGATION COULD NOT DETERMINE THE CAUSE OF THE REPORTED ISSUE BECAUSE THERE IS NO PROBLEM WITH THE PUMP FUNCTION, AND IT IS NOT REPRODUCIBLE. PREVENTIVELY, THE DOWNSTREAM OCCLUSION SENSOR WAS REPLACED AND RE-CALIBRATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HIGH PRESSURE CONTINUES ALARMING. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167693 CADD-SOLIS HCPA PUMP PUMP, INFUSION, PCA MEA SMITHS MEDICAL ASD, INC. 2110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown