BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FMS DUO+

    MDR report key: 2940958 · Received December 18, 2006

    Report

    Report Number
    2940958
    Event Type
    Injury
    Date Received
    December 18, 2006
    Date of Event
    December 4, 2006
    Report Date
    December 18, 2006
    Manufacturer
    FMS GROUP
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    (B)(6) 2006, 10:00 AM: ARTHROSCOPY PUMP MALFUNCTIONED DURING PROCEDURE CAUSING INCREASED PRESSURE IN RIGHT KNEE JOINT. (B)(6) 2006, 10:00 AM: WHILE PATIENT WAS UNDERGOING A KNEE DA PROCEDURE THERE WAS A MALFUNCTION OF THE FMS/MITEK IRRITATION PUMP KNOWN AS A FMS DUO+. THE PRESSURE INCREASED FROM 50 TO 150 CAUSING INCREASE PRESSURE AND SWELLING IN THE PATIENT'S RIGHT KNEE JOINT AND SURROUNDING TISSUE. THE ORTHOPEDIC SURGEON FOLLOWED UP WITH THE PATIENT POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FMS DUO+ ORTHOPEDIC PRODUCT: FLUID MANAGEMENT SYSTEM FRN FMS GROUP FMS DUO+

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention