BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 12215934 · Received July 23, 2021

    Report

    Report Number
    3012307300-2021-07546
    Event Type
    Malfunction
    Date Received
    July 23, 2021
    Report Date
    June 20, 2023
    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
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    .

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: 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 SAMPLES CONSIST OF TWO (2) CASSETTE UNITS FROM P/N 21-7302-24 L/N UNKNOWN; THE RETURNED SAMPLES WERE RECEIVED DECONTAMINATED INSIDE A PLASTIC BAG WHICH IS NOT ITS ORIGINAL PACKAGE. VISUAL INSPECTION RESULTS: THE SAMPLE DIDN?T PRESENT ANY DAMAGE, SCUFFS, PINCH MARKS, CRACKS, CRAZING, ETC. COULD CAUSE THE FAILURE MODE REPORTED. FUNCTIONAL TESTING: SAMPLES WERE FILLED WITH WATER; THE SAMPLES WERE CONNECTED TO THE CADD LEGACY PLUS TO LOOK FOR UNUSUAL FUNCTION. RESULTS: THE SAMPLES WERE FULLY PRIMING AND CONNECTED WITHOUT DIFFICULT, THE PUMP WERE SET RUNNING AND THE ALARM WERE NOT ACTIVATED. THE COMPLAINT WAS NOT CONFIRMED DUE TO SAMPLE WAS TESTED AND NO ALARMS WERE ACTIVATED. PER TREND REVIEW IN NO DISPOSABLE ALARM CODE AN ESCALATION TO INVESTIGATE THIS FAILURE WAS INITIATED ON (B)(6) 2021 UNDER NCR-000399 THAT IS IN CORRECTIVE ACTION PHASE. NO ACTIONS TAKEN WERE PERFORMED SINCE THE COMPLAINT WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED REGARDING A CADD CASSETTE RESERVOIR. IT WAS REPORTED THAT THE PUMP WAS ALARMING DUE TO DEFECTIVE CASSETTE. IT IS UNKNOWN IF THERE WAS PATIENT, OR CLINICIAN INJURY ASSOCIATED WITH THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1116932 CADD INTRAVASCULAR ADMINISTRATION SET FPA ST PAUL 21-7302-24 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown