BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS GO CANISTER 300ML

    MDR report key: 3764773 · Received April 22, 2014

    Report

    Report Number
    3006760724-2014-00262
    Event Type
    Malfunction
    Date Received
    April 22, 2014
    Date of Event
    January 3, 2012
    Report Date
    April 19, 2014
    Manufacturer
    SMITH AND NEPHEW WOUND MANAGEMENT
    Product Code
    BTA
    PMA / PMN Number
    K083375
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 CANISTER 300ML. ALTHOUGH THE KIT LOT NUMBER WAS NOT PROVIDED, PICTURES OF THE WOUND SITE WERE PROVIDED FOR VISUAL EXAMINATION. SINCE THE NEGATIVE PRESSURE THERAPY INVOLVES VARIOUS ELEMENTS WITHIN A SYSTEM (I.E. PUMP, CANISTER, SOFT PORT ETC.), IT IS DIFFICULT TO DETERMINE AND ASSIGN A DEFINITIVE ROOT CAUSE OF THE COMPLAINT DESCRIBED. AFTER EVALUATING THE PICTURES PROVIDED, POSSIBLE ROOT CAUSES FOR THE ACCUMULATION OF BLOOD AT THE WOUND SITE ARE BLOCKAGE CAUSED BY CLOTTING AT THE HEAD OF THE SOFT PORT WITH BLOOD CLOTS/EXUDATE, BLOCKAGE CAUSED BY PIECES OF LOOSE TRANSPARENT DRAPE CUT DURING PREPARATION OF THE WOUND SITE, OR HOLE CUT IN THE TRANSPARENT FILM NOT THE SIZE AS RECOMMENDED IN THE INSTRUCTIONS FOR USE. 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 AND 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. THE PICTURES PROVIDED SHOW THE SOFT PORT ¿UNCOMPRESSED¿ SHOWING THAT AN APPARENT BLOCKAGE HAD OCCURRED. HOWEVER, IT IS NOT CLEAR IF THE PICTURES PROVIDED WERE TAKEN WITH THE PUMP TURNED ¿ON¿ OR ¿OFF¿. 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, OR LOOSE ANTIMICROBIAL FILTER INSERTION COULD HAVE CAUSED A MINOR AIR LEAK BETWEEN PUMP AND CANISTER FILTER HOSE. IN ORDER FOR A BLOCKAGE ALARM TO BE TRIGGERED, THE FLUID HANDLING PATHWAY MUST BE ¿FULLY¿ OCCLUDED. IN THIS SCENARIO, AN ALARM WOULD HAVE BEEN TRIGGERED WITHIN 3 MINUTES. IF A LARGE BLOCKAGE OCCURS AT THE WOUND SITE AND AIR STILL REACHES THE SYSTEM, THE PUMP WILL NOT ALARM. ANALYZING ALL THE POSSIBLE ELEMENTS, THE PUMP DID NOT ALARM AS IT SENSED THAT PROPER NEGATIVE PRESSURE WAS ACHIEVED AND MAINTAINED BY THE SYSTEM, INCLUDING THE SOFT PORT. CIRCUMSTANCES LIKE INAPPROPRIATE WOUND/PUMP SETTING, OCCLUSION FROM THE DRAPE MATERIAL, FOAM MATERIAL OR EXUDATE TISSUE CAN PROVIDE A REASONABLE EXPLANATION FOR THE ACCUMULATION OF BLOOD UNDER THE DRAPE. 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

    FAILURE TO ALARM: THE PATIENT RECEIVED A MESH GRAFT TRANSPLANT WITH NEGATIVE PRESSURE WOUND THERAPY. THE SYSTEM WAS FUNCTIONING VERY WELL BUT AFTER A WHILE A NURSE FOUND OUT THAT A HUGE AMOUNT OF BLOOD STOOD UNDER THE DRAPE AND THE SOFT PORT WAS WITHOUT SUCTION. THE PUMP WAS WORKING AND NO ALARM OCCURRED. NO SUCTION IN SOFT PORT, ALTHOUGH RENASYS GO WAS RUNNING WITHOUT SHOWING ANY ERROR MESSAGE OR GIVING ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243541 RENASYS GO CANISTER 300ML PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) BTA SMITH AND NEPHEW WOUND MANAGEMENT 66800914 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1