BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHREX®

    MDR report key: 8603168 · Received May 13, 2019

    Report

    Report Number
    8603168
    Event Type
    Malfunction
    Date Received
    May 13, 2019
    Date of Event
    March 18, 2019
    Report Date
    April 30, 2019
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE SURGEON HAS CONCERNS THAT THE ARTHREX PUMP THAT WAS USED IN THE SURGERY WAS NOT CALIBRATED TO DELIVER THE CORRECT AMOUNT OF FLUID, CAUSING SWILLING IN THE PATIENT'S QUADRICEPS MUSCLE. PREVENTATIVE & CORRECTIVE MAINTENANCE RECORDS WERE REVIEWED AS WELL AS THE MANUFACTURES GUIDELINES OF USE. THE PUMP WAS USED AS DIRECTED. UPON RECEIVING THIS CONCERN, THE PUMP WAS TESTING AGAINST FACTORY SPECIFICATIONS WITH THE FOLLOWING RESULTS @ 10% FLOW: PRESSURE SET: 35, 50, 75, 100, 120; DISPLAY: 77, 110, 165, 220, 264; ACTUAL: 82, 116, 174, 229, 274. PER OUT BIOMED DEPARTMENT, THESE READINGS ARE WITHIN THE MANUFACTURER'S SPECIFICATIONS. THE PUMP HAS BEEN SEQUESTERED AND THE REMAINING PUMPS WILL BE EXCHANGED BY THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396518 ARTHREX® ARTHROSCOPE HRX ARTHREX, INC. AR-6475

    Patients

    Seq Age Sex Outcome Treatment
    1 12775 DA