BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION

    MDR report key: 16303984 · Received February 6, 2023

    Report

    Report Number
    3012307300-2023-00894
    Event Type
    Malfunction
    Date Received
    February 6, 2023
    Report Date
    April 3, 2023
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586043567
    PMA / PMN Number
    K111386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    WHILE PERFORMING A REVIEW OF ADDITIONAL 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-0182305 IS NO LONGER CONSIDERED REPORTABLE, AN MDR REPORT WILL BE FILED TO RETRACT ANY REPORTS ASSOCIATED WITH IT. RGN

    Description of Event or Problem · 0

    IT WAS REPORTED THE PUMP ALARMED CHECK SYRINGE FLANGE SENSOR. NO FURTHER DETAILS PROVIDED. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81635 MEDFUSION PUMP, INFUSION FRN ST PAUL 4000-0105-51 10610586043567

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown