BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARTHROSCOPY PUMP

    MDR report key: 34286 · Received July 19, 1996

    Report

    Report Number
    MW1009529
    Event Type
    Other
    Date Received
    July 19, 1996
    Date of Event
    July 10, 1996
    Report Date
    July 12, 1996
    Manufacturer
    MEDICAL PRODUCTS GROUP, 3M CO.
    Product Code
    HRX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS ADMITTED THROUGH DAY SURGERY WITH TORN MENSISCUS OF LEFT KNEE. LEFT KNEE ARTHROSCOPY WAS SCHEDULED ON 7/10/96. ON OR ABOUT 8:20 AM THE PROCEDURE BEGAN. AT 9:10AM THE PRESSURE SENSOR WAS NOTED TO BE DEFLATED. SENSOR WAS DISCONNECTED AND ALL LINES CHECKED. CASSETTE WAS REINSERTED IN THE ARTHROSCOPY PUMP AND SENSOR ALARM DID NOT SOUND. PROCEDURE WAS COMPLETED AT 9:25 AM. WHEN DRAPES WERE REMOVED SEVERE SWELLING WAS NOTED IN LEFT LOWER EXTREMITY. HOWEVER, PT WAS MONITORED IN RECOVERY ROOM. PEDAL PULSES REMAINED PALPABLE AND VITAL SIGNS STABLE. PT WAS TRANSFERRED OUT OF RR AT 11:45 AM IN STABLE CONDITION AND DISCHARGED HOME LATER THAT AFTERNOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHROSCOPY PUMP ARTHROSCOPY PUMP HRX MEDICAL PRODUCTS GROUP, 3M CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other