BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE 100ML W/ FLOWSTOP

    MDR report key: 9967265 · Received April 15, 2020

    Report

    Report Number
    MW5094151
    Event Type
    Malfunction
    Date Received
    April 15, 2020
    Date of Event
    March 30, 2020
    Report Date
    March 30, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    AE & PC OUTBOUND. REPORTS HAVING SIX CASSETTES THAT HAD AIR LEAKS IN THE TUBING ON TOP OF CASSETTE OR AT THE CONNECTION OF TUBING TO INNER MEDICATION RESERVOIR. SHE HAD A LOT OF CHAMPAGNE SIZED BUBBLES IN THE TUBING AND REPORTS THAT ON (B)(6) SHE HAD CHEST PAIN WHEN THIS OCCURRED. AFFECTED CASSETTES ARE 174920 CADD CASSETTE 100 ML WITH FLOWSTOP. LOT 3882469. 23-SEP-2024 X 6. NO FURTHER DETAILS PROVIDED CHEST PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429544 CADD CASSETTE 100ML W/ FLOWSTOP SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 174920 3882469
    429545 CADD CASSETTE 100ML W/ FLOWSTOP SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 174920 3882469
    429546 CADD CASSETTE 100ML W/ FLOWSTOP SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 174920 3882469
    429547 CADD CASSETTE 100ML W/ FLOWSTOP SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 174920 3882469
    429548 CADD CASSETTE 100ML W/ FLOWSTOP SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 174920 3882469
    429549 CADD CASSETTE 100ML W/ FLOWSTOP SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 174920 3882469

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR