BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE RESERVOIR

    MDR report key: 10374052 · Received August 6, 2020

    Report

    Report Number
    3012307300-2020-07890
    Event Type
    Malfunction
    Date Received
    August 6, 2020
    Date of Event
    July 1, 2020
    Report Date
    October 19, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    LHI
    UDI-DI
    10610586044014
    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 PICTURE OF A CADD CASSETTE RESERVOIR WAS RECEIVED AND REVIEWED. THE PICTURE SHOWED A YELLOW CONNECTOR AND NO DISCREPANCIES WERE FOUND. ONE CADD CASSETTE RESERVOIR FROM PART NUMBER 21-7600-24 AND UNKNOWN LOT NUMBER WAS RECEIVED IN USED CONDITION WITHOUT ITS ORIGINAL PACKAGING INSIDE A PLASTIC BAG FILLED WITH WATER. THE CASSETTE WAS VISUALLY INSPECTED, AT A DISTANCE OF 12" TO 24" AND NORMAL CONDITIONS OF ILLUMINATION. NO DISCREPANCIES WERE DETECTED. A SYRINGE WAS USED TO INFUSE WATER INTO THE ASSEMBLY (AY) BAG AND NO LEAKS WERE DETECTED. THE REPORTED LEAK WAS UNABLE TO BE CONFIRMED SINCE THERE WAS NO FAULT FOUND WITH THE RETURNED CASSETTE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT DURING THE USE OF A SMITHS MEDICAL CADD CASSETTE RESERVOIR AND A SMITH MEDICAL CADD EXTENSION SET, IT WAS NOTICED THAT MEDICAL FLUID WAS LEAKING FROM THE CONNECTION PART. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838349 CADD CASSETTE RESERVOIR SET, ADMINISTRATION, INTRAVASCULAR LHI SMITHS MEDICAL ASD, INC. 21-7609-24 10610586044014

    Patients

    Seq Age Sex Outcome Treatment
    1