BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYONICS 25 CONTROL UNIT

    MDR report key: 2463228 · Received February 21, 2012

    Report

    Report Number
    1643264-2012-00003
    Event Type
    Malfunction
    Date Received
    February 21, 2012
    Date of Event
    January 26, 2012
    Report Date
    January 26, 2012
    Manufacturer
    SMITH & NEPHEW OKLAHOMA CITY MANUFACTURING SITE
    Product Code
    HRX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SMITH & NEPHEW, INC. ENDOSCOPY DIVISION IS SUBMITTING THE ENCLOSED REPORT TO COMPLY WITH 21 CFR 803, THE MDR REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY SMITH & NEPHEW INC. ENDOSCOPY WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE OF THE REPORT WAS REQUIRED BY FDA. PRODUCT PASSED FUNCTIONAL TESTING PER PROCESS SUMMARY (B)(4) STEPS 5.1 THRU 5.4.9 WITH NO ERRATIC PRESSURE OR FLOW PROBLEMS. PRODUCT PASSED FUNCTIONAL TESTING DURING 48 HOUR BURN-IN ON WET STATION UTILIZING LOW AND HIGH PRESSURE AND FLOW SETTINGS. RAW AND ZERO TRANSDUCER READINGS NORMAL AND WELL WITHIN SPECS DURING ALL TESTS. NO PROBLEM FOUND. (B)(4).

    Description of Event or Problem · 1

    TEN MINUTES INTO THE CASE THE PUMP BECAME ERRATIC. IT WOULD NOT STOP PUMPING WHICH CAUSED THE KNEE TO SWELL UP IN WHICH SANDBAGS WERE USED TO REDUCE SWELLING. THE SURGEON CANCELLED THE CASE. ADDITIONAL INFORMATION STATES THAT SURGEON WAS USING A STORTZ HIGH FLOW CANNULA, DUAL VALVE, SETUP FOR INFLOW ONLY. TWO BAGS WERE SPIKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYONICS 25 CONTROL UNIT SVCE REPL,CONTROL UNIT, DYONICS 25 HRX SMITH & NEPHEW OKLAHOMA CITY MANUFACTURING SITE 7211010S ZN05364

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR