BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE !O0ML W/FLOWSTOP

    MDR report key: 10487843 · Received September 2, 2020

    Report

    Report Number
    MW5096413
    Event Type
    Malfunction
    Date Received
    September 2, 2020
    Date of Event
    August 23, 2020
    Report Date
    August 23, 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

    INTERNAL PC ONLY - INBOUND; PER HUSBAND, CASSETTE FROM LOT 21-73024 NOT USABLE ON EITHER PUMP, BOTH PUMPS CONTINUED TO BEEP TWO TONE RAPID BEEP AFTER END OF SELF TEST WITH REPORTED CASSETTE. MIXED DIFFERENT CASSETTE FROM SAME LOT AND ABLE TO RESTART INFUSION. NO FURTHER DETAILS PROVIDED. CASSETTE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950621 CADD CASSETTE !O0ML W/FLOWSTOP SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 21-7301-24

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR