BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 12053711 · Received June 23, 2021

    Report

    Report Number
    3012307300-2021-04836
    Event Type
    Malfunction
    Date Received
    June 23, 2021
    Date of Event
    April 22, 2021
    Report Date
    June 25, 2021
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586027239
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: D4) THE LOT NUMBER OF THE AFFECTED DEVICE IS 4092491.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SMITHS MEDICAL PUMP DISPLAYED A "NO DISPOSABLE TUBING PUMP WON'T RUN" WHEN THE CADD CASSETTE RESERVOIR WAS IN USE. SEVERAL NDA OVER THE LAST 2 DAYS. PATIENTS HAVE RETURNED TO CLINIC WITH NDA MID INFUSION AND PUMPS ARE NOT ABLE TO BE RESTARTED. NEW CASSETTES WERE PLACED ON ALL OF THE PUMPS AND PATIENTS WERE THEN SENT HOME TO COMPLETE THE INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948452 CADD SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7302-24 4092491 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1