BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD 100 ML MEDICATION CASSETTE RESERVOIR

    MDR report key: 9673338 · Received February 5, 2020

    Report

    Report Number
    3012307300-2020-00838
    Event Type
    Malfunction
    Date Received
    February 5, 2020
    Date of Event
    January 10, 2020
    Report Date
    May 13, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    UDI-DI
    10610586027239
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE CADD CASSETTE RESERVOIRS WAS RETURNED FOR ANALYSIS AND THE SAMPLE RECEIVED CONSIST IN ONE CASSETTE PRODUCT FORM P/N 21-7302-24 L/N 3882472. THE SAMPLE WAS RECEIVED IN USED CONDITIONS WITHOUT ITS ORIGINAL PACKAGING INSIDE IN A PLASTIC BAG. THE SAMPLE WAS VISUALLY INSPECTED, AT A DISTANCE OF 12" TO 24" AND NORMAL CONDITIONS OF ILLUMINATION AND THE CASSETTE SAMPLE HAD A MEDICATION INFORMATION LABEL. FUNCTIONAL TESTING WAS PERFORMED BY USING A SYRINGE TO INFUSE WATER INTO THE AY BAG AND LEAKING WAS DETECTED IN THE AY BAG, SPECIFICALLY LOCATED IN TOP CORNER NEAR PUMP TUBE CONNECTION. THE CUSTOMER'S REPORTED PROBLEM WAS CONFIRMED. ACCORDING TO THE INVESTIGATION THE MOST PROBABLE ROOT CAUSE IS, THAT DURING LEAK TEST OPERATION CASSETTE'S THAT FAILED (LEAK TEST), WERE NOT PROPERLY SEGREGATED. THE FOLLOWING ACTIONS WERE TAKEN, QUALITY ALERT WAS CREATED TO NOTIFY PRODUCTION PERSONNEL REGARDING CASSETTE PROPER SEGREGATION DURING LEAK TEST, TO AVOID FAILED CASSETTES BEEN MIXED AND TRAINING WAS PERFORMED BY PRODUCTION SUPERVISOR. THE PROBLEM SOURCE OF THE REPORTED PROBLEM IS MANUFACTURING.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CASSETTE WAS LEAKING. MORE SPECIFICALLY, THE BAG INSIDE OF THE CASSETTE WAS LEAKING. THERE WERE NO ADVERSE EVENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133207 CADD 100 ML MEDICATION CASSETTE RESERVOIR SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 21-7302-24 3882472 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1