BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 12569797 · Received October 4, 2021

    Report

    Report Number
    3012307300-2021-09748
    Event Type
    Malfunction
    Date Received
    October 4, 2021
    Date of Event
    September 2, 2021
    Report Date
    October 4, 2021
    Product Code
    FPA
    UDI-DI
    10610586027239
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SMITHS MEDICAL PUMP DISPOKAYED AN NDA UNRESOLVED WITH FLOWSTOP CASSETTE. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1470854 CADD SET, ADMINISTRATION, INTRAVASCULAR FPA 7300 4096352 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1