BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLUID MANAGEMENT SYSTEM

    MDR report key: 3136701 · Received May 23, 2013

    Report

    Report Number
    MW5030327
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    December 12, 2012
    Report Date
    May 23, 2013
    Manufacturer
    SMITH & NEPHEW
    Product Code
    HRX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING LEFT KNEE ARTHROSCOPY/AFTER INFUSING 6000 ML OF LR, IT WAS NOTED PT'S THIGH WAS QUITE SWOLLEN. INFUSION WAS STOPPED AND MEASURES TAKEN TO EXPRESS THE FLUID AND DECREASE THE SWELLING IN THE EXTREMITY. IT WAS FELT THIS WAS AT LEAST PARTLY DUE TO INEFFECTIVE EQUIPMENT USED (SMITH AND NEPHEW DYONICS FLUID PUMP/FLUID MGMT SYSTEM). NOTE: OUR STAFF DID NOT DOCUMENT EXACTLY WHICH LOT # PUMP WAS USED, SO THIS IS NOT AVAILABLE. IMMEDIATELY AFTER THIS OCCURRED WE TALKED WITH SMITH AND NEPHEW AND SENT BACK ALL PUMPS, EXCHANGING THEM FOR NEW PRODUCT. RETURNED: 2 EACH, CAT#7211010, CONTROL UNIT, S/N (B)(4); 4 EACH, CAT# 7211011, LEVERLERTII SENSOR, S/N (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227897 FLUID MANAGEMENT SYSTEM FLUID PUMP HRX SMITH & NEPHEW

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention