BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD MEDICATION CASSETTE

    MDR report key: 11917354 · Received June 1, 2021

    Report

    Report Number
    3012307300-2021-05370
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Report Date
    June 1, 2021
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586027239
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED LOT NUMBERS: 4089477; 4092491; 2101713; 4096396; 3965586; 2101927; 4066533; 4096351; 4072210.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT THE SMITHS MEDICAL CADD MEDICATION CASSETTE WAS CAUSING A NO DISPOSABLE ALARM ON THE PUMP, AND WOULD NOT ATTACH CORRECTLY TO THE PUMP. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810717 CADD MEDICATION CASSETTE SET, ADMINISTRATION, INTRAVASCULAR, FPA ST PAUL 21-7302-24 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1