BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHROSCOPY PUMP

    MDR report key: 128484 · Received October 23, 1997

    Report

    Report Number
    128484
    Event Type
    Injury
    Date Received
    October 23, 1997
    Date of Event
    October 10, 1997
    Report Date
    October 22, 1997
    Manufacturer
    3 M HEALTHCARE
    Product Code
    HRX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT'S RT LEG/THIGH SWELLED WITH .9NS DURING ARTHROSCOPY. APPROXIMATELY 5,3,000CC BAGS USED DURING CASE. 3,500CC WERE ACCOUNTED FOR. NOTED AT BEGINNING OF CASE A MINIMAL AMOUNT OF FLUID RETURNING. SCRUB NURSE WAS QUESTIONED ABOUT EXCESSIVE FLUID USE. PUMP APPEARED TO WORK FINE. CHECKED PATIENT'S UPPER LEG AND NOTED INCREASED SWELLING AND INFORMED SURGEON, CASE WAS STOPPED. VASCULAR SURGEON WAS CALLED TO EXAMINE PATIENT. PATIENT TRANSFERRED TO PACU IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHROSCOPY PUMP ORTHOPEDIC PRODUCTS HRX 3 M HEALTHCARE 8700 *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization