BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION

    MDR report key: 16098860 · Received January 4, 2023

    Report

    Report Number
    3012307300-2023-00107
    Event Type
    Malfunction
    Date Received
    January 4, 2023
    Report Date
    March 6, 2023
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586043567
    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

    OTHER, OTHER TEXT: THIS FILE SHOULD NOT HAVE BEEN DETERMINED TO BE REPORTABLE. PLEASE DISREGARD ANY MDRS ASSOCIATED WITH THIS FILE. 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-0181328 IS NO LONGER CONSIDERED REPORTABLE, PLEASE DISREGARD ANY MDRS ASSOCIATED WITH IT.

    Additional Manufacturer Narrative · 0

    OPERATOR OF DEVICE IS UNKNOWN. NO INFORMATION HAS BEEN PROVIDED TO DATE. 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.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: ADDITIONAL INFORMATION WAS RECEIVED. THE BIOMEDICAL ENGINEER STATED THAT HE HAS NO INTERACTION WITH THE PATIENTS AND UNAWARE OF ANY COMPLIANCE ISSUES WITH THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE HOLDER IS OUT OF ALIGNMENT. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT, NO OBSERVABLE CLINICAL SYMPTOMS, OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1177539 MEDFUSION PUMP, INFUSION FRN ST PAUL 4000 10610586043567

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown