BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS F MEDIUM WITH SOFT PORT

    MDR report key: 3759754 · Received April 18, 2014

    Report

    Report Number
    3006760724-2014-00175
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    November 5, 2012
    Report Date
    April 11, 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
    NJ, 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 MEDIUM WITH SOFT PORT. REDDENING/IRRITATIONS ARE KNOWN ISSUES WITH ANY ADHESIVE DRESSING IN PATIENTS THAT HAVE CERTAIN SKIN CONDITIONS OR CERTAIN SENSITIVE SKIN TYPES. S& N HAS TESTED & ASSESSED THE SAFETY OF THE NEGATIVE PRESSURE WOUND THERAPY DRAPES AND HAS DETERMINED THAT THEY ARE SAFE FOR ITS INTENDED USE. REGARDING DRESSING LIFTING, POSSIBLE ROOT CAUSE COULD BE LOCATION OF WOUND AND/OR PATIENT MOVEMENT THAT COULD HAVE PROVEN TO BE A CHALLENGE IN OBTAINING/ MAINTAINING A SEAL DURING THERAPY. THE RENASYS SYSTEM PROVIDES BLOCKAGE DETECTION IF THERE IS A BLOCKAGE TO AIR FLOW SUCTIONED INTO THE PUMP FROM SYSTEM CONNECTIONS THAT INCLUDE AT LEAST A CANISTER AND THE WOUND DRESSING. THE PUMP BY ITSELF ALARMS TO BLOCKAGE/CANISTER FULL IF IN THE RANGE OF 0.0 L/MIN-0.05 L/MIN FOR WHICH THE PUMP MOTOR OPERATION DRIVES THE ALARM ELECTRONICALLY. 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. A POSSIBLE ROOT CAUSE IS THAT IN THE NORMAL OPERATION OF THE SOFT PORT, DRESSING ABSORBED EXUDATES THAT SLOWED DOWN THE TRANSPORT OF FRESHLY PULLED EXUDATES IN SYSTEM. IN THAT CIRCUMSTANCE, THE PUMP MAINTAINED NEGATIVE PRESSURE AND CANISTER WAS RECEIVING A SMALLER VOLUME DUE TO PARTIAL OCCLUSION IN SOFT PORT. THIS ISSUE HAS BEEN CONFIRMED. CAR2346 WAS INITIATED TO FURTHER INVESTIGATE THE ROOT CAUSES FOR FAILURES OF THIS TYPE & IDENTIFY ANY POTENTIAL CORRECTIVE ACTIONS. 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

    REDDENING: NPWT REGISTERED AS WORKING UNTIL THE PATIENT WAS TURNED AND DRAPE WAS 1/4 OFF WOUND. ALSO, FAILURE TO ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238335 RENASYS F MEDIUM WITH SOFT PORT PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) BTA SMITH & NEPHEW WOUND MANAGEMENT 66800795 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other