BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS EZ NEGATIVE PRESSURE WOUND THERAPY

    MDR report key: 3769854 · Received April 24, 2014

    Report

    Report Number
    3006760724-2014-00297
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    November 14, 2011
    Report Date
    April 21, 2014
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    BTA
    PMA / PMN Number
    K082426
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 EZ NEGATIVE PRESSURE WOUND THERAPY. THIS ISSUE WAS NOT CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. THE ROOT CAUSE OF THE REPORTED ISSUE CANNOT BE DETERMINED. A POSSIBLE ROOT CAUSE IS A BLOCKAGE CAUSED BY THE CLOT AT THE WOUND SITE, AS REPORTED. THE RENASYS SYSTEM PROVIDES BLOCKAGE DETECTION FROM THE CONTROLLED LEAK PATH (THE T-CONNECTOR) TO THE CANISTER. BY DESIGN, THE DEVICE WILL NOT ALARM FOR BLOCKAGE IF THE OCCLUSION IS BELOW THE T-CONNECTOR (CONTROLLED LEAK PATH) ON THE WOUND SIDE. IT IS RECOMMENDED THAT THE DEVICE BE RETURNED FOR INVESTIGATION TO RULE OUT A POSSIBLE DEVICE MALFUNCTION. THE RENASYS EZ DEVICE HAS BEEN REPLACED BY THE RENASYS EZ PLUS, WHICH HAS SOME NEW FEATURES AND MODIFICATIONS. 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: DRESSING WAS LEAKING SANGUINOUS DRAINAGE, LARGE BLOOD CLOT FOUND UNDER DRESSING AND PUMP WAS NOT ALARMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250294 RENASYS EZ NEGATIVE PRESSURE WOUND THERAPY PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) BTA SMITH & NEPHEW WOUND MANAGEMENT 66800059

    Patients

    Seq Age Sex Outcome Treatment
    1 Other