BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 11752034 · Received April 30, 2021

    Report

    Report Number
    11752034
    Event Type
    Malfunction
    Date Received
    April 30, 2021
    Date of Event
    April 23, 2021
    Report Date
    April 27, 2021
    Manufacturer
    SMITHS MEDICAL MD, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    OVER A PERIOD OF A FEW DAYS, SEVERAL PATIENTS RECEIVING 46 HOUR CONTINUOUS INFUSION 5-FU FROM CANCER CENTER REPORTED PUMP ALARMS BEEPING AFTER SEVERAL HOURS OF THE INFUSION RUNNING. ALARM NOTE STATES "NO DISP. PUMP WON'T RUN" DESPITE THE CASSETTE CLEARLY ATTACHED TO PUMP. FIRST INTERVENTION WAS TO SWAP OUT PUMP WITH NEW PUMP WHICH WORKED FOR SEVERAL PATIENTS. IN OTHER CASES, NEW CASSETTES WERE MADE FOR THE REMAINING DRUG TO INFUSE. THE CASSETTES INVOLVED WERE 100 ML. THE BELIEF IS THAT IT IS LIKELY THAT THE INVOLVED LOT NUMBERS WERE 4084909, 4095686 AND 4092493. IT IS BELIEVED THAT OUR OTHER INVENTORY IS LESS LIKELY TO BE INVOLVED (LOT NUMBERS:3962247,3983320,4060911,4084910).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653188 CADD SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL MD, INC. 21-7302-24

    Patients

    Seq Age Sex Outcome Treatment
    1