BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 10405050 · Received August 13, 2020

    Report

    Report Number
    3012307300-2020-08169
    Event Type
    Malfunction
    Date Received
    August 13, 2020
    Date of Event
    July 15, 2020
    Report Date
    October 21, 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

    EVALUATION RESULTS: A CADD CASSETTE SET (NINE PRODUCTS) WERE RETURNED FOR INVESTIGATION IN USED CONDITION. THE NINE UNITS WERE VISUALLY INSPECTED AT A DISTANCE OF 12 TO 16 INCHES UNDER NORMAL CONDITIONS OF ILLUMINATION. NO DAMAGES OR OTHER WORKMANSHIP DEFECTS WERE OBSERVED. THE CASSETTES WERE THEN CONNECTED TO A CADD LEGACY PUMP FOR TESTING. THE PUMP RAN THE DELIVERY PROGRAM WITHOUT ANY ISSUES. NO ALARMS WERE ACTIVATED DURING THE TESTS. NO FAULT WAS FOUND WITH THE CASSETTES. THE INVESTIGATOR DETERMINED THAT THEY FUNCTIONED AS INTENDED. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT.

    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
    866233 CADD ACCESSORIES FLOW-STOP FPA ST PAUL CASSETTE 100 ML 3900379 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1