BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 10597645 · Received September 28, 2020

    Report

    Report Number
    3012307300-2020-09928
    Event Type
    Malfunction
    Date Received
    September 28, 2020
    Date of Event
    August 14, 2020
    Report Date
    March 16, 2021
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586027239
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION COMPLETED ON A SMITHS MEDICAL AMBULATORY AMBULATORY INFUSION PUMPS/CADD CASSETTE RESERVOIRS - FLOW STOP. TWO SAMPLES P/N 21-7302-24 L/N 3922201. VISUAL INSPECTION REVEALED NO DISCREPANCIES UNDER NORMAL PROTOCOL. WHEN DEVICE WAS THREADED INTO LEGACY PLUS, NO ALARMS OR MALFUNCTIONED OCCURRED. THE ENGINEERING AND TESTING WAS REVIEWED WITH NO DISCREPANCIES PRIOR TO RELEASE. NO FAULT COULD BE FOUND OR ESTABLISHED.

    Description of Event or Problem · 0

    DEVICE EVALUATION COMPLETED.

    Description of Event or Problem · 1

    INFORMATION RECEIVED A SMITH MEDICAL AMBULATORY INFUSION PUMPS/CADD CASSETTE RESERVOIRS - FLOW STOP ALARMED HIGH PRESSURE DURING CONNECTING THE CASSETTE. THE ISSUE OCCURRED WITH ANOTHER PUMP WITH ATTACHING CASSETTE. ONCE CASSETTE WAS CHANGED THE ISSUE WAS RESOLVED. THE MEDICATION BEING DELIVERED WAS APOKINON FOR TREATMENT OF MUSCLE STIFFNESS, PAIN AND CONTROL. IT WAS REPORTED NO ADVERSE EVENTS OCCURRED WITH PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1061917 CADD CASSETTE FPA ST PAUL 21-7302-24 3922201 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR