BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD MEDICATION CASSETTES

    MDR report key: 14602361 · Received June 6, 2022

    Report

    Report Number
    3012307300-2022-10769
    Event Type
    Malfunction
    Date Received
    June 6, 2022
    Report Date
    October 3, 2022
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586027239
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT OR PHOTOGRAPHIC EVIDENCE WERE PROVIDED TO AID IN THIS INVESTIGATION. THE COMPLAINT REPORT OFFERED INSUFFICIENT DETAILS TO DETERMINE WHETHER THIS PRODUCT FUNCTIONED AS INTENDED, OR WAS USED IN A MANNER CONSISTENT WITH ITS INSTRUCTIONS FOR USE (IFU) OR FAILED TO MEET PRODUCT SPECIFICATIONS. LACKING ANY ADDITIONAL EVIDENCE, THIS COMPLAINT HAS BEEN CLOSED AS UNCONFIRMED. IF THE PRODUCT IS RETURNED, SMITHS MEDICAL WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION. A MANUFACTURING DHR REVIEW WAS NOT PERFORMED BECAUSE THE RESULTS OF THE COMPLAINT INVESTIGATION DO NOT INDICATE A PROBLEM WITH THE MANUFACTURE OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: H6: EVENT PROBLEM AND EVALUATION CODES: UPDATES NOT REQUIRED. H10: NO PRODUCT WAS RETURNED FOR VISUAL OR FUNCTIONAL EVALUATION. RESULTS: WE ARE UNABLE TO CONFIRM THE REPORTED COMPLAINT AS NO SAMPLE WAS RECEIVED FOR INVESTIGATION. ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AS NO SAMPLE WAS RECEIVED. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE., CORRECTED DATA: D5: CORRECTION: OPERATOR OF THE DEVICE: PATIENT OR CONSUMER, G3: CORRECTION: REPORT SOURCE: (B)(4), G5: CORRECTION: PREMARKET 510K: K040636

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CASSETTE SHE HAD ISSUES WITH THE OTHER DAY LOT NUMBER IS 4213377. ALSO, A CASSETTE YESTERDAY WAS PUT ON, BUT STARTED ALARMING NO DISPOSABLE ALARMS (LOT NUMBER IS 4220000). NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185472 CADD MEDICATION CASSETTES SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7302-24 4213377 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown