BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION

    MDR report key: 16127290 · Received January 9, 2023

    Report

    Report Number
    3012307300-2023-00294
    Event Type
    Malfunction
    Date Received
    January 9, 2023
    Report Date
    February 13, 2023
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586041242
    PMA / PMN Number
    K111386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    WHILE PERFORMING A REVIEW OF THE ADDITIONAL INFORMATION RECEIVED, THE CUSTOMER STATED: "NO INTERACTION WITH PATIENTS AND I AM UNAWARE OF ANY ADVERSE EVENTS WITH PATIENTS RELATING TO THIS DEVICE". NO PATIENT DEATH, SERIOUS INJURY, AND NO EVIDENCE OF A REPORTABLE PRODUCT MALFUNCTION. THE REVISED 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-0181587 IS NO LONGER CONSIDERED REPORTABLE, PLEASE DISREGARD ANY MDR REPORTS ASSOCIATED WITH IT.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A RETURNED ORDER SERVICE A FAILED SENOR ERROR OCCURRED. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255791 MEDFUSION PUMP, INFUSION FRN ST PAUL 3500-0600-01 10610586041242

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown