BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD MEDICATION CASSETTE

    MDR report key: 15015842 · Received July 14, 2022

    Report

    Report Number
    3012307300-2022-13357
    Event Type
    Malfunction
    Date Received
    July 14, 2022
    Date of Event
    June 10, 2022
    Report Date
    November 30, 2022
    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
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT INFORMATION HAS BEEN PROVIDED TO DATE. NO INFORMATION HAS BEEN PROVIDED TO DATE. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    H6: EVENT PROBLEM AND EVALUATION CODES: UPDATES ARE NOT REQUIRED. NO PRODUCT WAS RETURNED THEREFORE, NO VISUAL OR FUNCTIONAL EVALUATION CAN BE PERFORMED. WE ARE UNABLE TO CONFIRM THE REPORTED COMPLAINT AS NO SAMPLE WAS RECEIVED FOR INVESTIGATION. ROOT CAUSE OF THE REPORTED EVENT IS UNKNOWN AND CANNOT BE DETERMINED AS NO SAMPLE WAS RECEIVED. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION. NO LOT NUMBER WAS PROVIDED THEREFORE, A MANUFACTURING DEVICE HISTORY RECORD DHR REVIEW COULD NOT BE PERFORMED., CORRECTED DATA: D4: CORRECTION: UNIQUE DEVICE IDENTIFIER: (B)(4), D4: CORRECTION: CATALOG NUMBER: 21-7302-24, G5: CORRECTION: PREMARKET 510K: K040636

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A NO DISPOSABLE ALARM ON BOTH PUMPS WAS EXPERIENCED. THE USE OF A NEW CASSETTE RESOLVED THE ALARM. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2350078 CADD MEDICATION CASSETTE SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7302-24 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown