BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTROL UNIT, DYONICS 25

    MDR report key: 2983088 · Received February 28, 2013

    Report

    Report Number
    1643264-2013-00004
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 2013
    Manufacturer
    SMITH & NEPHEW INC. OKLAHOMA CITY MANUFACTURING
    Product Code
    HRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER COMPLETION OF A KNEE ARTHROSCOPY USING OUR DYONICS 25 PUMP. WHEN DR. UNDRAPED PATIENT HE NOTICED PATIENT WAS SWOLLEN (DISTENDED) FROM THE VAGINA AREA TO THE TOP OF HER ABDOMEN AND THAT HER FOOT WAS PURPLE AND NO PULSE IN THE FOOT. SURGEON GAVE PATIENT LASIX AND THE SWELLING AND BLOOD PRESSURE STARTED TO DROP AND FOOT SWELLING STARTED TO GO DOWN. DR. STATED THEY HAD THE PUMP SET AT 100 AND THEY WENT THROUGH 5 BAGS OF FLUID WHEN NORMALLY THEY ONLY USE 2 AND THAT THERE WAS VERY LITTLE ON THE FLOOR. ADDITIONAL INFORMATION INDICATES THE PATIENT WENT HOME SAME DAY FROM SURGERY CENTER. PUMP WAS TAKEN OUT OF SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87090 CONTROL UNIT, DYONICS 25 CONTROL UNIT, DYONICS 25 HRX SMITH & NEPHEW INC. OKLAHOMA CITY MANUFACTURING

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention