BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP, CONTINUOUS WAVE III

    MDR report key: 1003847 · Received February 15, 2008

    Report

    Report Number
    1220246-2008-00016
    Event Type
    Injury
    Date Received
    February 15, 2008
    Date of Event
    November 24, 2007
    Report Date
    January 21, 2008
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO HAS BEEN REQUESTED FROM THE USER FACILITY IN REGARDS TO THE RETURN OF THE DEVICE. NO RESPONSE HAS BEEN RECEIVED TO THIS DATE. A NEW CUSTOMER CONTACT WAS MADE ON 02/14/08. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER AN ARTHROSCOPIC IRRIGATION AND DEBRIDEMENT OF THE RIGHT KNEE, THE PT PRESENTED EDEMA TO THE RIGHT UPPER THIGH, LOWER ABDOMEN AND GENITALS. THE PUMP WAS SET AT 80MMHG AND 100 FLOW. A TOTAL OF FIVE 3L BAGS OF LACTATED RINGERS, AND ONE 3L AND ONE 1L BAGS OF BACITRACIN IRRIGATION WERE USED. CUSTOMER REPORTS THE PT WAS TAKEN TO THE RECOVERY ROOM (PACU) ALERT AND ORIENTED. NO FURTHER PT INFORMATION NOR EVENT DETAILS ARE AVAILABLE FROM THE CUSTOMER AS OF THE SUBMISSION DATE OF THIS REPORT. THIS DEVICE IS USED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP, CONTINUOUS WAVE III ARTHROSCOPIC PUMP HRX ARTHREX, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN