BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE RESERVOIRS - FLOW STOP

    MDR report key: 16095149 · Received January 4, 2023

    Report

    Report Number
    3012307300-2023-00055
    Event Type
    Malfunction
    Date Received
    January 4, 2023
    Report Date
    July 7, 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 CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.THE LOT/SERIAL NUMBER WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: CUSTOMER RESPONSE EMAIL RECEIVED WITH NEW INFORMATION PROVIDED BY THE CUSTOMER, THERE WAS NO PATIENT INVOLVEMENT. THEREFORE, NO PATIENT DEATH, SERIOUS INJURY, AND NO EVIDENCE OF A REPORTABLE PRODUCT MALFUNCTION. THE HAZARDOUS SITUATION FOR THE GIVEN COMPLAINT DEVICE WOULD NOT LIKELY CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. FILE CC-0180852 IS NO LONGER CONSIDERED REPORTABLE, PLEASE DISREGARDS ANY REPORTS ASSOCIATED WITH IT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE EXHIBITED A NO DISPOSABLE ALARM. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    898683 CADD CASSETTE RESERVOIRS - FLOW STOP SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7302-24 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown