BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS GO NEGATIVE PRESSURE WOUND THERAPY

    MDR report key: 3770131 · Received April 24, 2014

    Report

    Report Number
    3006760724-2014-00314
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    November 2, 2011
    Report Date
    April 22, 2014
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    BTA
    PMA / PMN Number
    K083375
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 (B)(4) 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 GO NEGATIVE PRESSURE WOUND THERAPY. DISCLAIMER: SMITH & NEPHEW, INC. IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY SMITH & NEPHEW, INC., WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS ISSUE WAS CONFIRMED UPON EVALUATION OF THE RETURNED DEVICE. THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE DUE TO A LEAKY PUMP. THE PUMP WAS REPLACED AND THE DEVICE PASSED ALL FUNCTIONAL TESTING. 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: NURSE ON WARD COMMENTED THAT THE DRESSING WAS LEAKING AND EXUDATE ESCAPING BUT THE PUMPS WERE NOT ALARMING TO SAY THAT A LEAK HAD DEVELOPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248666 RENASYS GO NEGATIVE PRESSURE WOUND THERAPY PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) BTA SMITH & NEPHEW WOUND MANAGEMENT 66800164

    Patients

    Seq Age Sex Outcome Treatment
    1 Other