BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS G LARGE W/SOFT PORT

    MDR report key: 3770133 · Received April 24, 2014

    Report

    Report Number
    3006760724-2014-00310
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    February 20, 2013
    Report Date
    April 23, 2014
    Manufacturer
    SMITH AND NEPHEW WOUND MANAGEMENT
    Product Code
    BTA
    PMA / PMN Number
    K110647
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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: (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 W/ SOFT PORT. SMITH & NEPHEW RECEIVED THE ABOVE REPORTED COMPLAINT FOR FUNCTIONAL. THE COMPLAINT INDICATES THAT TWO (2) SOFT PORTS WERE BEING USED. FROM THE COMPLAINT REPORT, IT WAS LEARNED THAT BOTH WERE ON THE LOWER LEG (ONE WAS LOCATED ON THE DORSAL FOOT AND ONE ON THE CALF). IT IS ASSUMED THAT A Y-CONNECTION CONFIGURATION WAS USED HOWEVER, COULD NOT BE CONFIRMED WITH THE COMPLAINT INFORMATION. PATIENT CAUSED ONE (1) DRESSING TO LIFT WHILE THE OTHER STAYED ON PATIENT. NO LEAK ALARM WAS DETECTED. THE FACT THAT NO LEAK ALARM WAS DETECTED INDICATES THAT 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. THE PUMP OPERATES NORMALLY FOR LEAK RATES UP TO A RANGE OF 2.5 -3.5 L/MIN, BUT IS DESIGNED TO ALARM FOR EXCESSIVE LEAK IF TRIGGERED BY PRESSURE DIFFERENTIALS BETWEEN PRESSURE SELECTOR SETTING AND THE SUSTAINED PRESSURE MEASURED ON GAUGE, REACTING AS AN INDICATION THAT THE DESIRED SUSTAINED PRESSURE IS NOT STABLE DUE TO A LEAK. IN SUMMARY, THE PUMP IN SYSTEM CONNECTION WILL BE SENSITIVE TO LEAK RATES BELOW 0.05 L/MIN AND TO INSTABILITY IN PRESSURE HELD FOR SYSTEM WHEN NEGATIVE PRESSURE CANNOT BE SUSTAINED WITHIN 25MMHG OF SETTING. ANALYZING ALL THE POSSIBLE ELEMENTS, THE LEAKAGE ALARM WAS NOT TRIGGERED COULD HAVE BEEN CAUSED BY PARTIAL OR COMPLETE OCCLUSION OF THE COMPROMISED SOFT PORT 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. THE COMPLAINT IS DEEMED UNDETERMINED. 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 KICKED OFF THE ENTIRE SOFT PORT OF THE DRESSING. EZ PLUS ALARMED INITIALLY, BUT ONCE THE PORT WAS REPLACED THE DRESSING SUCKED DOWN AND NO ALARM SIGNALLED. THERE WERE TWO PORT DRESSINGS ON THIS PATIENT. ONCE THE DRESSING WAS COMPROMISED AND SUBSEQUENTLY REPAIRED HE COMPROMISED THE DRESSING AGAIN A DAY LATER. IN SPITE OF THE DRESSING BEING COMPROMISED THE OTHER PORT SHOULD HAVE BEEN FUNCTIONING AND YET THE LEAK ALARM DID NOT SOUND! THERE WERE TWO SEPARATE INCIDENCES ON THIS PATIENT RELATED TO THE DEVICE NOT ALARMING WITH A OBVIOUSLY COMPROMISED DRESSING. NO HARM TO PATIENT AND PATIENT WAS SENT HOME AFTER DRESSING CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249110 RENASYS G LARGE W/SOFT PORT PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) BTA SMITH AND NEPHEW WOUND MANAGEMENT 66800935 2012060794

    Patients

    Seq Age Sex Outcome Treatment
    1