BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS GO NPWT DEVICE

    MDR report key: 3754059 · Received April 16, 2014

    Report

    Report Number
    3006760724-2014-00106
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    October 21, 2013
    Report Date
    April 15, 2014
    Manufacturer
    SMITH AND NEPHEW WOUND MANAGEMENT
    Product Code
    BTA
    PMA / PMN Number
    K083375
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED BY SMITH & NEPHEW AS A RESULT OF A RETROSPECTIVE REVIEW OF COMPLAINTS, INCLUDING ADVERSE EVENTS, AS PART OF CORRECTIVE AND REMEDIATION ACTIONS FOLLOWING THE ISSUANCE OF THE 483 ISSUED NOVEMBER 26, 2013 TO SMITH & NEPHEW, INC. FEI NO: 3006160724. SMITH & NEPHEW IS PERFORMING A TWO-YEAR RETROSPECTIVE REVIEW OF COMPLAINT FILES TO RE-ASSESS REPORTABILITY CRITERIA AND REPORTING DECISIONS MADE FOR COMPLAINTS RECORDED DURING THE TIME PERIOD UNDER REVIEW. THIS COMPLAINT HAS BEEN RE-ASSESSED IN ACCORDANCE UNDER THE PROVISIONS OF 21CFR 803.50 AND DEEMED REPORTABLE AS AN MDR. WE ARE SUBMITTING ONE (1) INITIAL, 30 DAY REPORT, MEDWATCH FDA FORM 3500A, FOR A PURPORTED DEVICE MALFUNCTION WHICH OCCURRED WHILE USING THE RENASYS GO. THE PRESSURE SETTING WAS AT 120 MMHG AS ORDERED AND AT THE DOCTOR¿S OFFICE THE DRESSING WAS IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU). HOWEVER, AT THE PATIENT¿S HOME THE HOME HEALTH HOME ADMIN (HHA) WAS NOT FOLLOWING THE IFU. THE PATIENT STATED HE HAD BEEN TELLING THEM (HHA) TO CUT THE HOLE THE SIZE OF A QUARTER, BUT THEY WERE BARELY CUTTING IT THE SIZE OF A DIME. THE PATIENT PROBLEMS WERE OCCURRING AFTER HIS HH DRESSING CHANGES. EVERYTHING WAS FINE AFTER THE DOCTOR¿S WAS CHANGING HIS DRESSING (S&N WAS PRESENT FOR THOSE). PER CLINICIAN, THE SOFT PORT OPENING IS .25 INCHES (0.6CM) IN DIAMETER. IT IS IMPORTANT THAT THE OPENING IN THE WOUND TRANSPARENT FILM IS .25 INCHES (0.6CM) IN DIAMETER AS WELL. THIS REPORT IS DEEMED INCONCLUSIVE, IT IS DIFFICULT TO DETERMINE AND ASSIGN A DEFINITIVE ROOT CAUSE OF THE COMPLAINT DESCRIBED WITHOUT DEVICE EVALUATION. THE SOFT PORT ACHIEVES NEGATIVE PRESSURE BY DRAWING AIR THROUGH THE AERATION DISK LOCATED DISTAL TO THE WOUND SITE AND CLOSE TO THE QUICK-CLICK CONNECTOR. AIR FLOWS ON THE TOP FOAM LAYER (AERATION PATHWAY) TO THE WOUND, EXUDATE AND ADMITTED AIR IS REMOVED THROUGH THE BOTTOM LAYER (FLUID HANDLING PATHWAY). WHEN NEGATIVE PRESSURE IS ACHIEVED, THE SOFT PORT WILL APPEAR ¿COMPRESSED¿ WITH A ¿RAISIN-LIKE¿ TEXTURE. REGARDING PUMP NOT ALARMING, POSSIBLE ROOT CAUSES MAY INCLUDE: SYSTEM WAS DRAWING ENOUGH AIR THROUGH THE QUICK-CLICK CONNECTOR. SYSTEM WAS DRAWING ENOUGH AIR THROUGH THE CANISTER CONNECTION. SYSTEM WAS DRAWING ENOUGH ADMITTED AIR THROUGH THE FLUID HANDLING PATHWAY. LOOSE ANTIMICROBIAL FILTER INSERTION; CAUSED A MINOR AIR LEAK BETWEEN PUMP AND CANISTER FILTER HOSE. A DHR REVIEW FOR THE DEVICE INDICATED NO DISCREPANCIES OR REWORK ON THIS DEVICE. ALL RENASYS GO PUMPS ARE TESTED AND VERIFIED TO MEET SPECIFICATIONS PRIOR TO RELEASE. THERE WAS NO FURTHER INFORMATION THAT INDICATED PATIENT INJURY ON THE FOLLOW UP INFORMATION OBTAINED. AS A RESULT OF SIMILAR COMPLAINTS SMITH & NEPHEW HAS ISSUED (B)(4) TO INITIATE RENASYS PRODUCT LABELING UPDATES. THESE LABELLING UPDATES WILL PROVIDE ENHANCED INFORMATION ON THE FUNCTIONALITY OF THE ALARMS AS THEY RELATE TO THE DESIGN OF THE DEVICE, AND SCENARIOS THAT CAN OCCUR IN CLINICAL SETTINGS WHICH MAY IMPACT ALARM FUNCTIONALITY.

    Description of Event or Problem · 1

    PATIENT WAS BROUGHT INTO MD OFFICE FOR ANOTHER DRESSING CHANGE POST KNEE SURGERY. SMALL OPEN ARE IN MIDDLE OF INCISION REMAINS, HOWEVER WOUND HAS BEEN FILLING IN NICELY. STAPH INFECTION IN WOUND, PATIENT IS BEING TREATED WITH IV ABX. ALSO SUGGESTED FLEX AT LAST DRESSING CHANGE AND MD AGREED TO USE OF FLEX 3. PT. STATES THAT PUMP FUNCTIONS WELL AFTER DRESSING IS DONE IN MD OFFICE, THEN WHEN HH DOES DRESSING CHANGE, RNS ARE NOT CUTTING HOLE BIG ENOUGH IN SPITE OF IN-SERVICING AND PATIENT REMINDING THEM TO DO SO. FLUID THEN BEGINS TO ACCUMULATE UNDER TRANSPARENT FILM, AND LEAK DOWN UNDER DRESSING. THIS HAS HAPPENED A TOTAL OF 3-4 TIMES DURING TREATMENT WITH NPWT AND PUMP HAS NEVER ALERTED WITH A LEAK ALARM. PT. IS ALERTED WHEN CLOTHING BECOMES WET OR HIS PERI-WOUND BECOMES PAINFUL. HAVE CHANGED OUT THE PUMP AND PULLED PUMP FROM CIRCULATION FOR QUALITY TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233048 RENASYS GO NPWT DEVICE PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) BTA SMITH AND NEPHEW WOUND MANAGEMENT 66800164

    Patients

    Seq Age Sex Outcome Treatment
    1