BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD ADMINISTRATION SET WITH FLOW STOP

    MDR report key: 14625554 · Received June 7, 2022

    Report

    Report Number
    3012307300-2022-11000
    Event Type
    Malfunction
    Date Received
    June 7, 2022
    Date of Event
    May 10, 2022
    Report Date
    September 28, 2022
    Manufacturer
    ST PAUL
    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

    OTHER TEXT: H4: DEVICE MANUFACTURE DATE COULD NOT BE COMPLETED DUE TO LACK OF INFORMATION REGARDING LOT NUMBER. H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED. H3: DEVICE EVALUATED BY MANUFACTURER: UPDATED. H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED. VISUAL INSPECTION FOUND NO DAMAGE, KINKS OR ANY DISCREPANCIES THAT COULD CAUSE THE FAILURE MODE REPORTED. FUNCTIONAL TESTING SHOWED THAT THE SAMPLE WAS FULLY PRIMING AND CONNECTED WITHOUT DIFFICULT, THE PUMP WAS SET RUNNING AND NO ALARMS WERE ACTIVATED. COMPLAINT WAS NOT CONFIRMED. NO ROOT CAUSE WAS DETERMINED FOR REPORTED PROBLEM AND NO SUBSEQUENT ACTIONS WERE TAKEN AS THE COMPLAINT WAS NOT CONFIRMED. NO LOT NUMBER WAS PROVIDED; THEREFORE, DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED. AN INTERNAL CAPA HAS BEEN OPENED AND THIS ISSUE WILL BE MONITORED FOR ANY INCREASE IN OCCURRENCE. IF THE OCCURRENCE OF THIS ISSUE INCREASES SIGNIFICANTLY, ADDITIONAL CORRECTIVE ACTIONS WILL BE TAKEN, CORRECTED DATA: CORRECTION: B5:DESCRIBE EVENT OR PROBLEM: UPDATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE USE OF THE CASSETTE, CADD RESERVOIR CASSETTE DISPLAYED A "NO MESSAGE" ALARMF. THE CUSTOMER CHANGED THE PUMP TO ANOTHER ONE, BUT THE ALARM PERSISTED. SO HE CHANGED THE CASSETTE TO ANOTHER ONE, AND NO ALARM SOUNDED. THE PUMPS USED TOGETHER WITH THE CASSETTES WERE 21-6500-09. NO PATIENT INJURY WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE USE OF THE CASSETTE, THE DEVICE DISPLAYED A NO MESSAGE ALARM. THE CUSTOMER CHANGED THE PUMP TO ANOTHER ONE, BUT THE ALARM PERSISTED. SO HE CHANGED THE CASSETTE TO ANOTHER ONE, WHICH RESOLVED THE ISSUE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525973 CADD ADMINISTRATION SET WITH FLOW STOP SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7302-24 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female