BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 14654136 · Received June 10, 2022

    Report

    Report Number
    3012307300-2022-11488
    Event Type
    Malfunction
    Date Received
    June 10, 2022
    Report Date
    March 27, 2023
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586019548
    PMA / PMN Number
    K982838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED. H10: PRODUCT IS BEYOND 19 (NINETEEN) YEARS FROM MANUFACTURE DATE OF 2003-03 AND THERE WAS NO INDICATION OF A MANUFACTURING DEFECT DURING THE INVESTIGATION, SO A DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT PERFORMED. A SERVICE HISTORY REVIEW IDENTIFIED THIS DEVICE HAS NOT BEEN IN FOR SERVICE IN THE PREVIOUS 3 (THREE) YEARS AND THERE WAS NO INDICATION OF A SERVICE ISSUE DURING THE INVESTIGATION. A PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WAS PERFORMED. VISUAL INSPECTION FOUND NO PHYSICAL DAMAGE. FUNCTIONAL TESTING FOUND THE REPORTED COMPLAINT WAS VERIFIED. ENTERED SERVICE MODE AND THE DEVICE STARTED TO DOUBLE BEEP. THE DOWN STREAM OCCLUSION SENSOR WILL NEED TO BE REPLACED. THE ROOT CAUSE OF THE ISSUE COULD NOT BE DETERMINED. THIS ISSUE WILL BE MONITORED FOR ANY INCREASE IN OCCURRENCE. IF THE OCCURRENCE OF THIS ISSUE INCREASES SIGNIFICANTLY, ADDITIONAL INVESTIGATIVE ACTION WILL BE TAKEN ACCORDINGLY. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4),AS A RESULT OF WARNING LETTER CMS# (B)(4). CORRECTED DATA: D4: CORRECTION: MODEL NUMBER: 6400.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DOUBLE BEEP NO CASSETTE DURING TESTING WAS EXPERIENCED. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678379 CADD PUMP,INFUSION FRN ST PAUL 6400 10610586019548

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown