BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE RESERVOIRS

    MDR report key: 12327725 · Received August 16, 2021

    Report

    Report Number
    3012307300-2021-08478
    Event Type
    Malfunction
    Date Received
    August 16, 2021
    Date of Event
    July 11, 2021
    Report Date
    March 2, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    UDI-DI
    10610586027239
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED AFTER DEVICE EVALUATION . H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. A VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED. SAMPLES RECEIVED: THE SAMPLE CONSIST OF ONE CASSETTE UNIT FROM P/N 21-7302-24 L/N 4114183; THE RETURNED SAMPLE WAS RECEIVED DECONTAMINATED INSIDE A PLASTIC BAG. VISUAL INSPECTION RESULTS: THE SAMPLE DIDN?T PRESENT ANY DAMAGE, SCUFFS, PINCH MARKS, CRACKS, CRAZING, ETC. COULD CAUSE THE FAILURE MODE REPORTED. FUNCTIONAL TESTING: THE SAMPLE WAS FILLED WITH WATER; THE SAMPLES WERE CONNECTED TO THE CADD LEGACY PLUS [CAL. ID: 1.0383; DUE DATE: 09/2021] TO LOOK FOR UNUSUAL FUNCTION. RESULTS: THE SAMPLE WAS FULLY PRIMING AND CONNECTED WITHOUT DIFFICULT, THE PUMP WERE SET RUNNING AND THE ALARM WERE NOT ACTIVATED. THE COMPLAINT WAS NOT CONFIRMED. THE CAUSE OF THE REPORTED PROBLEM COULD NOT BE DETERMINED. PER TREND REVIEW IN NO DISPOSABLE ALARM CODE AN ESCALATION TO INVESTIGATE THIS FAILURE WAS INITIATED ON MARCH 08, 2021 UNDER NCR-000399 THAT IS IN CORRECTIVE ACTION PHASE. NO ACTIONS WERE TAKEN SINCE THE COMPLAINT WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT DURING PRIOR TO USE OF THIS SMITHS MEDICAL CADD CASSETTE RESERVOIRS, THE PUMP EXHIBITED "NO DISPOSABLE, PUMP WON'T RUN" ALARM. THE PATIENT SWITCHED TO A DIFFERENT PUMP AND CASSETTE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1224441 CADD CASSETTE RESERVOIRS SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 21-7302-24 4114183 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1 Female