BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NRFIT

    MDR report key: 10495434 · Received September 4, 2020

    Report

    Report Number
    3012307300-2020-09054
    Event Type
    Malfunction
    Date Received
    September 4, 2020
    Date of Event
    August 6, 2020
    Report Date
    November 9, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    LHI
    UDI-DI
    10610586044007
    PMA / PMN Number
    K162219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: H3: ONE CADD CASSETTE RESERVOIR FROM PART NUMBER 21-7600-24 WAS RECEIVED IN USED CONDITION WITHIN ITS ORIGINAL PACKAGE. THE SAMPLE WAS VISUALLY INSPECTED AT A DISTANCE OF 12" TO 16" UNDER NORMAL CONDITIONS OF ILLUMINATION. A SYRINGE WAS USED TO INFUSE WATER INTO THE CASSETTE BAG. NO LEAKS WERE FOUND. LEAK TESTING WAS REVIEWED TO ENSURE THAT MEASURES ARE WITHIN SPECIFICATION, NO DISCREPANCIES WERE FOUND. THE CAUSE OF THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED SINCE NO OCCLUSION WAS FOUND ON THE RETURNED CASSETTE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT THE CADD CASSETTE RESERVOIRS - FLOW STOP LEAKED. WHEN MEDICATION WAS BEING FILLED IN THE CASSETTE, IT LEAKED FROM THE CONNECTION PART. THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960594 NRFIT SET, ADMINISTRATION, INTRAVASCULAR LHI SMITHS MEDICAL ASD, INC. 21-7600-24 3883724 10610586044007

    Patients

    Seq Age Sex Outcome Treatment
    1