BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOGOS

    MDR report key: 9738970 · Received February 21, 2020

    Report

    Report Number
    1000391282-2020-00001
    Event Type
    Malfunction
    Date Received
    February 21, 2020
    Report Date
    February 21, 2020
    Manufacturer
    MILESTONE S.R.L.
    Product Code
    IEO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE WAITING FOR EVALUATE THE MESH FILTER FOR EVALUATION.

    Description of Event or Problem · 1

    DUE TO A FOREIGN BODY EXTERNAL TO THE FUNCTIONALITIES, PRESENT INSIDE THE CAVITY WITH THE REAGENTS, DIFFICULTIES WERE ENCOUNTERED IN THE DIAGNOSIS OF THE SAMPLES. HOWEVER, THEY HAVE ALL BEEN RECOVERED AND DIAGNOSED. DURING A PHASE OF UNLOADING THE REAGENT FROM THE CAVITY TOWARDS THE TANK, DESPITE THE PRESENCE OF THE MESH FILTER, THE FOREIGN BODY FOLLOWED THE REAGENT REACHING THE VALVE MEMBRANE. AT THIS POINT THE FOREIGN BODY GOT STUCK IN THE MEMBRANE PREVENTING AN ADEQUATE CLOSURE OF THE VALVE SO THAT, DURING THE CONTINUATION OF THE PROCESSING, THERE WAS A CONTAMINATION OF THE REAGENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205646 LOGOS AUTOMATED TISSUE PROCESSOR IEO MILESTONE S.R.L. 61502/140

    Patients

    Seq Age Sex Outcome Treatment
    1 Other