BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 11842643 · Received May 18, 2021

    Report

    Report Number
    3012307300-2021-04531
    Event Type
    Malfunction
    Date Received
    May 18, 2021
    Date of Event
    April 19, 2021
    Report Date
    May 18, 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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED REGARDING A CADD CASSETTE RESERVOIR. IT WAS REPORTED THAT THERE HAS BEEN AN INCREASE IN NO DISPOSABLE ALARMS WHILE USING LOTS 4092491 AND 4084027. THREE PATIENTS HAD A NO DISPOSABLE ALARM WITH LOT 4092491 AND 1 PATIENT HAD THE ALARM WITH 4094027. THERE WAS NO PATIENT, OR CLINICIAN INJURY ASSOCIATED WITH THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738929 CADD INTRAVASCULAR ADMINISTRATION SET FPA ST PAUL 21-7302-24 4084027 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1