BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICATION CASSETTE RESERVOIR CADD

    MDR report key: 11936568 · Received June 3, 2021

    Report

    Report Number
    3012307300-2021-05475
    Event Type
    Malfunction
    Date Received
    June 3, 2021
    Report Date
    May 10, 2022
    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 HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO ROOT CAUSE COULD BE DETERMINED SINCE THE COMPLAINT WAS NOT CONFIRMED DUE TO THE FACT NO SAMPLES, PICTURES OR VIDEOS WERE RECEIVED TO PERFORM A THOROUGH INVESTIGATION. NO LOT NUMBER WAS PROVIDED; THEREFORE, DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE END USER HAS HAD THREE NDA ALARMS WITH THE LEGACY PLUS. THERE WAS NO PATIENT INVOLVEMENT OR INJURY REPORTED.

    Additional Manufacturer Narrative · 1

    LOT NUMBER OF PRODUCT NOT PROVIDED TO SMITHS MEDICAL.

    Description of Event or Problem · 1

    (B)(4) MEMORIAL HOSPITAL IN (B)(4), HAS HAD THREE NDA ALARMS WITH THE LEGACY PLUS AND THE 21-7302-24.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832644 MEDICATION CASSETTE RESERVOIR CADD SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7302-24 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown