BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD MEDICATION CASSETTE RESERVOIR

    MDR report key: 10508200 · Received September 9, 2020

    Report

    Report Number
    3012307300-2020-09130
    Event Type
    Malfunction
    Date Received
    September 9, 2020
    Date of Event
    July 1, 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

    ONE CADD CASSETTE RESERVOIR FROM PART NUMBER 21-7600-24 AND UNKNOWN LOT NUMBER WAS RETURNED FOR EVALUATION. THE SAMPLE WAS VISUALLY INSPECTED AT A DISTANCE OF 12" TO 16" UNDER NORMAL CONDITIONS OF ILLUMINATION, NO ABNORMALITIES OR ASSEMBLY ISSUES WERE DETECTED OTHER THAN A KINK IN THE TUBE. A SYRINGE WAS USED TO INFUSE WATER INTO THE CASSETTE BAG. THE SAMPLE DID NOT LEAK. RELEVANT DOCUMENTS WERE REVIEWED AND DEEMED ADEQUATE AND CORRECT WITH RESPECT TO TESTING AND INSPECTION ACTIVITIES . THE CAUSE OF THE ISSUE COULD NOT BE DETERMINED SINCE NO FAILURES WERE FOUND IN THE SAMPLE RECEIVED FOR EVALUATION. THE ONLY ITEM DETECTED WAS THE KINKED TUBE BUT IT DID NOT LEAK.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A LEAK WAS OBSERVED TO A SMITHS MEDICAL CADD MEDICATION CASSETTE RESERVOIR DURING INFUSION. THE LEAK WAS NOTED TO BE COMING FROM THE CONNECTION PART. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    974774 CADD MEDICATION CASSETTE RESERVOIR SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 21-7600-24 10610586044007

    Patients

    Seq Age Sex Outcome Treatment
    1