BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 10112836 · Received June 2, 2020

    Report

    Report Number
    3012307300-2020-05413
    Event Type
    Malfunction
    Date Received
    June 2, 2020
    Report Date
    August 17, 2020
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586027536
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3: 20 CADD ADMINISTRATION SETS FROM P/N 21-7394-24 L/N 3951901 WERE RECEIVED IN USED CONDITIONS INSIDE A PLASTIC BAG WITH THEIR ORIGINAL PACKAGING. THE SAMPLES WERE VISUALLY INSPECTED AT A DISTANCE OF 12? TO 16? UNDER NORMAL CONDITIONS OF ILLUMINATION. DELAMINATION WAS FOUND AT LEAST ONE JOIN OF THE FILTER WITH THE TUBE IN THE SAMPLES RECEIVED. LEAK TESTING ON THE SAMPLES RECEIVED WERE PERFORMED USING HYDROSTAT VESSEL TO LOOK FOR UNUSUAL FUNCTIONS. FOR TWENTY SAMPLES RECEIVED, ONLY FOUR SAMPLES WERE TESTED DUE TO THE CONFIRMATION OF REPORTED FAILURE MODE; LEAK WAS OBSERVED FLEEING FROM FILTER. RELEVANT DOCUMENTS WERE REVIEWED AND DEEMED ADEQUATE AND CORRECT WITH RESPECT TO TESTING AND INSPECTION ACTIVITIES. THE REPORTED ISSUE WAS ABLE TO BE DUPLICATED. THE ISSUE WAS CAUSED BECAUSE FILTERS WET OUT AND CAN LEAK IF SURFACTANTS (OILY) SUBSTANCES FLOW THROUGH THEM LOWER SURFACE TENSION FLUID.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL TUBING WAS LEAKING FROM THE FILTER. THIS WAS REPORTED TO HAVE BEEN HAPPENING WITH MULTIPLE TUBINGS FROM THIS LOT. THIS ISSUE OCCURRED TWICE WHILE INFUSING THE PATIENT. WHEN THIS ISSUE OCCURRED, THE INFUSION WAS STOPPED AND THE PUMP AND TUBING WAS CHANGED TO GRAVITY INFUSION. THERE WAS NO ADVERSE EVENTS REPORTED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574401 CADD FPA ST PAUL 21-7394-24 3915901 10610586027536

    Patients

    Seq Age Sex Outcome Treatment
    1