BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYONICS 25 SYSTEMS

    MDR report key: 1916648 · Received December 7, 2010

    Report

    Report Number
    1643264-2010-00017
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    October 29, 2010
    Report Date
    November 8, 2010
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY OKLAHOMA CITY MANUFACTURE
    Product Code
    HRX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SMITH & NEPHEW, INC. ENDOSCOPY DIV 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 DIV WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE OF THE REPORT WAS REQUIRED BY FDA. PUMP TRANSDUCER P1 FAILED RAW OUTPUT TEST AT 37.0MMHG. SPECS ARE 0.0 MMHG WITH RANGE OF +/- 15MMHG. PUMP FAILED WET TEST. READINGS SETTING AT IDLE ON WET STATION ARE 40MMHG PRESSURE AT 0.0 L/M FLOW. PUMP WAS READING BLANK ON PRESSURE READING AND 0.9 L/M FLOW SETTING AT IDLE. REPLACED TRANSDUCER P1 WITH A TEST TRANSDUCER AND UNIT PASSED FUNCTIONAL AND WET TESTS WITH READINGS WELL WITHIN SPECS. TRANSDUCER WAS MANUFACTURED 12TH WEEK OF 2006 AND IS OVER 4 YEARS OLD. ROOT CAUSE OF PUMP MALFUNCTION IS TRANSDUCER P1 SERIAL NUMBER (B)(4) AND DATE CODE 1206. (B)(4).

    Description of Event or Problem · 1

    PRESSURE SET TO 40MMG. EXTREME EXTRAVASATION WITNESSED IN COMPLETE ARM AND UPPER HALF TORSO. ANESTHETIST VERY ANXIOUS AND PATIENT WAS REFERRED TO SPECIALIST FOR POST OP CARE AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYONICS 25 SYSTEMS CONTROL UNIT, DYONICS 25 HRX SMITH & NEPHEW ENDOSCOPY OKLAHOMA CITY MANUFACTURE 7211010 ZN02324

    Patients

    Seq Age Sex Outcome Treatment
    1