BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHREX ARTHROSCOPY PUMP TUBING

    MDR report key: 8758066 · Received July 1, 2019

    Report

    Report Number
    MW5087791
    Event Type
    Malfunction
    Date Received
    July 1, 2019
    Date of Event
    June 12, 2019
    Report Date
    June 12, 2019
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SENSOR IN FLUID CHAMBER OF ARTHROSCOPY PUMP TUBING NOTED TO BE "FLAT" IN APPEARANCE. DID NOT REGULATE THE INFLOW OF IRRIGATION FLUID TO LEFT KNEE, CAUSING FLUID SUBLIGATION TO SUBCUTANEOUS TISSUE LEFT KNEE TO GROIN. DIAGNOSIS OR REASON FOR USE: ARTHROSCOPY, LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545063 ARTHREX ARTHROSCOPY PUMP TUBING ARTHROSCOPE HRX ARTHREX, INC. 32454024

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR