BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS SOFT PORT STAND ALONE

    MDR report key: 3758658 · Received April 18, 2014

    Report

    Report Number
    3006760724-2014-00151
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    July 31, 2012
    Report Date
    April 16, 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
    PA, 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 SOFT PORT STAND ALONE. SMITH & NEPHEW RECEIVED THE ABOVE REPORTED COMPLAINT FOR FAILURE TO ALARM. NO SAMPLES, PICTURES OR LOT NUMBER INFORMATION WERE PROVIDED OR RECEIVED FOR EVALUATION, THEREFORE, A DEVICE HISTORY RECORD REVIEW INVESTIGATION COULD NOT BE PERFORMED WITH THE LIMITED INFORMATION PROVIDED. REGARDING DRESSING DETACHED FROM PATIENT, A REASONABLE EXPLANATION COULD BE THAT THE DRESSING BECAME DETACHED DUE TO THE LOCATION OF THE WOUND. COMPLAINT DESCRIPTION INCLUDES THAT THE NURSE NOTED DRESSING DETACHED WHEN PATIENT WAS ¿ROLLED OVER¿ INDICATING LOCATION MIGHT HAVE PROVEN TO BE CHALLENGING IN MAINTAINING A SEAL. REGARDING PUMP NOT LEAK ALARMING, 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 PUMP 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. 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 AS REPORTED, AND CANISTER WAS RECEIVING A SMALLER VOLUME DUE TO PARTIAL OCCLUSION IN SOFT PORT. THIS ISSUE HAS BEEN CONFIRMED. 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: SOFT PORT DETACHED FROM PATIENT, NO ALARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237891 RENASYS SOFT PORT STAND ALONE PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) BTA SMITH & NEPHEW WOUND MANAGEMENT 66800799 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other