BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 10404773 · Received August 13, 2020

    Report

    Report Number
    3012307300-2020-08167
    Event Type
    Malfunction
    Date Received
    August 13, 2020
    Date of Event
    July 15, 2020
    Report Date
    October 17, 2020
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586027239
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: INVESTIGATION COMPLETED ON A SMITHS MEDICAL AMBULATORY INFUSION PUMPS/CADD CASSETTE RESERVOIRS - FLOW STOP . NINE SAMPLES PRODUCTS RETURNED AFTER DECONTAMINATION P/N 21-7302-24. VISUAL INSPECTION UNDER PROTOCOL MD01-003 REV. 102. SECTION 3.0 REVEALED NO DAMAGE OR DISCREPANCIES. FUNCTIONAL TESTING WAS DONE BY CONNECTING THE CADD LEGACY PUMP AND NO ALARMS WERE DETECTED. REVIEWED QUALITY REVIEW WHICH REVEALED PERFORMED TESTING AT 100 %. THE COMPLAINT ROOT CAUSE COULD NOT BE DETERMINED AS COMPLAINT WAS NOT VERIFIED. NO ACTIONS ARE REQUIRED SINCE THE COMPLAINT WAS NOT CONFIRMED AND CANNOT ATTRIBUTE TO MANUFACTURING PROCESS. HOWEVER, MANUFACTURING PERSONNEL WAS NOTIFIED BY THE QUALITY ENGINEER ON 23-SEP-2020 AS AWARENESS OF THE FAILURE MODE REPORTED BY THE CUSTOMER.

    Description of Event or Problem · 0

    INVESTIGATION COMPLETED ON A SMITHS MEDICAL AMBULATORY INFUSION PUMPS/CADD CASSETTE RESERVOIRS - FLOW STOP.

    Description of Event or Problem · 1

    INFORMATION RECEIVED A SMITHS MEDICAL AMBULATORY INFUSION PUMPS/CADD CASSETTE RESERVOIRS - FLOW STOP ON THREE DIFFERENT OCCASIONS LOT DOCUMENTED 3935920, 3894451, 3900379 ALARMS UPSTREAM OCCLUSION ALARM. NO PATIENT ADVERSE EVENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865950 CADD FLOW STOP ACCESSORIES FPA ST PAUL 21-7302-24 3935920 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1