BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICATION CASSETTE RESERVOIR

    MDR report key: 9671628 · Received February 5, 2020

    Report

    Report Number
    3012307300-2020-00938
    Event Type
    Malfunction
    Date Received
    February 5, 2020
    Date of Event
    January 1, 2020
    Report Date
    May 21, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3: ONE CADD CASSETTE RESERVOIR FROM P/N 21-7302-24 L/N 3834164 WAS RECEIVED IN USED CONDITION WITHOUT ITS ORIGINAL PACKAGING INSIDE A PLASTIC BAG. THE SAMPLE WAS VISUALLY INSPECTED, AT A DISTANCE OF 12" TO 24" AND NORMAL CONDITIONS OF ILLUMINATION. THE CASSETTE SAMPLE HAD A MEDICATION INFORMATION LABEL. A SYRINGE WAS USED TO INFUSE WATER INTO THE ASSEMBLY (AY) BAG. A LEAK WAS DETECTED IN THE AY BAG, SPECIFICALLY LOCATED IN TOP CORNER NEAR PUMP TUBE CONNECTION. THE MOST PROBABLE CAUSE OF THIS ISSUE IS, THAT DURING LEAK TEST OPERATION, THE CASSETTES THAT FAILED (LEAK TEST), WERE NOT PROPERLY SEGREGATED.

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: FOREIGN COUNTRY: (B)(6).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD MEDICATION CASSETTE INFUSING FLORAN WAS LEAKING FROM THE PART WHERE THE LUER-LOCK CONNECTOR WAS CONNECTED. IT WAS REPORTED THAT USE OF THE PRODUCT WAS SUBSEQUENTLY STOPPED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137219 MEDICATION CASSETTE RESERVOIR SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 21-7302-24 3834164 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1