BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS F LARGE WITH SOFT PORT

    MDR report key: 3756801 · Received April 17, 2014

    Report

    Report Number
    3006760724-2014-00114
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    September 3, 2012
    Report Date
    April 14, 2014
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    BTA
    PMA / PMN Number
    K110647
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. (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 F LARGE WITH SOFT PORT. SMITH & NEPHEW RECEIVED THE ABOVE REPORTED COMPLAINT FOR AN ADVERSE EVENT. NO PICTURES, NO SAMPLES AND NO LOT NUMBER INFORMATION WERE PROVIDED FOR EVALUATION. COMPLAINT INDICATES THAT TWO (2) SOFT PORTS WERE Y-CONNECTED (RIGHT AND LEFT LEG). DRESSING ON RIGHT LEG WAS ¿COMPRESSED¿ AND WORKING APPROPRIATELY HOWEVER; DRESSING ON LEFT LEG WAS NOT COMPRESSED AND HAD POOLING OF FLUID. THE FACT THAT ONE DRESSING WAS COMPRESSED INDICATES THAT NEGATIVE PRESSURE (VACUUM) WAS PRESENT FOR THE ENTIRE SYSTEM, INCLUDING THE WOUND SITE WITH POOLING. THE FACT THAT A BLOCKAGE ALARM WAS NOT TRIGGERED IS BECAUSE THE SYSTEM WAS SENSING THAT PROPER NEGATIVE PRESSURE WAS ACHIEVED BY MEANS OF THE SOFT PORT THAT WAS WORKING PROPERLY AND SUSTAINED NEGATIVE PRESSURE IN SYSTEM CONNECTIONS, EVEN IF POOLING WAS DEVELOPING AT THE LEFT LEG WOUND. ANALYZING ALL THE POSSIBLE ELEMENTS, THE POOLING ON THE WOUND ON THE LEFT LEG COULD HAVE BEEN CAUSED BY PARTIAL OR COMPLETE OCCLUSION OF THE DRAIN WITH EXUDATE OR PRESSURE HEAD DIFFERENTIALS WHICH COULD HAVE FAVORED THE OUTFLOW OF EXUDATES FROM A PARTICULAR WOUND SITE WITHIN THE Y-CONNECTED SYSTEM, ESPECIALLY IN PATHWAY OF LEAST RESISTANCE. A VERIFICATION OF CONNECTION COULD HAVE BEEN PERFORMED BY CAPPING THE RIGHT LEG SOFT PORT JUNCTION OF THE Y-CONNECTOR AND ALLOWING JUST THE LEFT LEG WOUND SITE TO INFLOW TO CANISTER. THE RIGHT LEG SOFT PORT WAS ¿COMPRESSED¿ INDICATES THAT SUCCESSFUL NEGATIVE PRESSURE WAS OBTAINED. THE COMPLAINT IS DEEMED UNCONFIRMED. 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

    FAILURE TO ALARM: POOLING OF FLUID UNDER THE FILM BUT THE DRESSING AND THE SOFT PORT WERE NO LONGER COMPRESSED- THERE WAS A TIGHT SEAL ALL AROUND THE DRESSING, ALTHOUGH NO ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235774 RENASYS F LARGE WITH SOFT PORT PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) BTA SMITH & NEPHEW WOUND MANAGEMENT 66800796 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other