BEUDAMED
    FDA Adverse Event Summary report: N

    RENASYS G MEDIUM W/SOFT PORT

    MDR report key: 3753889 · Received April 16, 2014

    Report

    Report Number
    3006760724-2014-00104
    Date Received
    April 16, 2014
    Date of Event
    October 7, 2013
    Report Date
    April 15, 2014
    Manufacturer
    SMITH AND NEPHEW WOUND MANAGEMENT
    Product Code
    BTA
    PMA / PMN Number
    K110647
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. (B)(4). 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 G MEDIUM W/SOFT PORT. THE COMPLAINT IS INCONCLUSIVE AND NO PRODUCT WAS ABLE TO BE EVALUATED. HOWEVER, THE CIRCUMSTANCES OF THE DESCRIBED COMPLAINT HAVE OCCURRED BEFORE. SINCE NEGATIVE PRESSURE THERAPY INVOLVES VARIOUS ELEMENTS WITHIN A SYSTEM (I.E. PUMP, CANISTER, SUCTION PORT ETC), IT IS DIFFICULT TO DETERMINE A DEFINITIVE ROOT CAUSE FOR THE FAILURE TO ALARM. POSSIBLE ROOT CAUSES FOR POOLING OF FLUID AT THE WOUND SITE ARE A BLOCKAGE CAUSED BY CLOTTING AT THE HEAD OF THE SOFT PORT OR GRADUAL BLOCKAGE/BUILDUP OF BLOOD CLOTS/EXUDATE INSIDE THE SOFT PORT FLUID HANDLING PATHWAY. A LEAK ALARM IS DESIGNED TO TRIGGER IF THE SYSTEM DETECTS A SIGNIFICANT LEAK. A POTENTIAL CAUSE OF THE PUMP NOT TRIGGERING A LEAK ALARM IS THAT THERE WAS A BLOCKAGE IN THE SYSTEM AT THE SAME TIME AS A LEAK, RESULTING IN THE SYSTEM BEING ABLE TO HOLD THE REQUIRED NEGATIVE PRESSURE. IN ORDER FOR A BLOCKAGE ALARM TO BE TRIGGERED THE FLUID HANDLING PATHWAY MUST BE FULLY OCCLUDED. IF THE BLOCKAGE OCCURS AT THE WOUND SITE OR WITHIN THE FLUID HANDLING PATHWAY AND AIR IS STILL REACHING THE PUMP, THE ALARM WILL NOT SOUND. IN THE INSTANCE WHERE THERE WAS A BLOCKAGE DETECTED BUT NO ALARM, THE PUMP LIKELY SUSTAINED ENOUGH OF A FLOW RATE OF AIR TO PREVENT A BLOCKAGE ALARM FROM SOUNDING. AS A RESULT OF SIMILAR COMPLAINTS SMITH & NEPHEW HAS ISSUED CAR02714 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

    FAILURE TO ALARM THE ISSUE IS WITH A BLOCKAGE FORMING ON THE GAUZE SIDE OF THE SOFT PORT, RESULTING IN THE POOLING AND EVENTUAL LEAKAGE OF DRAINAGE OUT OF THE SIDES OF THE DRESSING DRAPE. ALL THIS WITH NEITHER A LEAKAGE OR BLOCKAGE ALARM COMING FROM THE PUMP. THEY ARE ABLE TO LIFT THE DRESSING COMPLETELY OFF THE WOUND AFTER IT PEELS OFF, WITH THE PUMP RUNNING, AND NO LEAK OR BLOCKAGE IS DETECTED. WE HAVE TRIED INCREASING THE PRESSURE TEMPORARILY, MORE FREQUENT DRESSING CHANGES, THE NEW SOFT PORT WITH LARGER OPENING, NEW SOFTWARE VERSION IN PUMP, AND SELECTING SMALLER, LOWER DRAINING WOUNDS. NOTHING SEEMS TO KEEP THIS ISSUE FROM HAPPENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232275 RENASYS G MEDIUM W/SOFT PORT PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) BTA SMITH AND NEPHEW WOUND MANAGEMENT 66800934

    Patients

    Seq Age Sex Outcome Treatment
    1