BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS GO NPWT DEVICE

    MDR report key: 3813179 · Received May 15, 2014

    Report

    Report Number
    3006760724-2014-00342
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    December 18, 2013
    Report Date
    June 16, 2014
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    BTA
    PMA / PMN Number
    K083375
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS CONSIDERED INCONCLUSIVE DUE TO LACK OF INFORMATION. NO SAMPLES OR LOT NUMBERS INFORMATION WERE PROVIDED. WITHOUT A DEVICE SERIAL NUMBER A DEVICE HISTORY RECORD OR COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED. SINCE THE NEGATIVE PRESSURE WOUND THERAPY INVOLVES VARIOUS ELEMENTS, IT IS DIFFICULT TO DETERMINE AND ASSIGN AN EXACT ROOT CAUSE FOR THE ISSUE REPORTED. NO INFORMATION WAS GIVEN ON EXACT WOUND LOCATION, SIZE, TYPE OF DRESSING APPLICATION, PUMP PLACEMENT, AND PRESSURE SETTINGS BASED ON THE INFORMATION PROVIDED, IT MAY BE HELPFUL TO REVIEW DRESSING APPLICATION, PUMP PLACEMENT, CHOICE OF WOUND FILLER, AND PRESSURE SETTINGS WITH CLINICIAN. IN ACCORDANCE WITH CLINICAL GUIDELINES, IT IS IMPORTANT THAT HOLE IN TRANSPARENT FILM BE CUT TO 0.6CM AND OPENING IN SOFT PORT IS PROPERLY ALIGNED WITH OPENING IN TRANSPARENT FILM TO ENSURE A GOOD SEAL AND DECREASE RISK OF POOLING. ADDITIONALLY, PER CLINICAL GUIDELINES AN INCREASE IN THE PRESSURE MAY BE NECESSARY ACCORDING TO SIZE OF WOUND, VISCOSITY OF EXUDATE, AMOUNT OF EXUDATE AND CLINICAL JUDGMENT OF DESIRED WOUND OUTCOMES. LOSS OF DRESSING SEAL (ADHESION) COULD BE ATTRIBUTED TO A COMBINATION OF FACTORS SUCH AS WOUND LOCATION, PATIENT MOBILITY, CONSTANT FRICTION, PRESSURE DIRECTLY APPLIED TO WOUND SITE, ACCUMULATION OF MOISTURE UNDERNEATH THE DRESSING, AND PROPER PREPARATION OF THE PERIWOUND SKIN AS PER CLINICAL GUIDELINES.

    Additional Manufacturer Narrative · 1

    ACTIVE INVESTIGATION IN PROGRESS; RESULTS OF INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENT REPORT.

    Description of Event or Problem · 1

    FAILURE TO ALARM THE ISSUE IS THAT EXSUDATE IS NOT REMOVED WELL ENOUGH, POOLS IN THE WOUND AND THAT THE SURROUNDING SKIN GETS MACERATED AND THE FILM COMES LOOSE. IN SEVERAL CASES THE ALARM WAS NOT TRIGGERED.

    Description of Event or Problem · 1

    FAILURE TO ALARM THE ISSUE IS THAT EXSUDATE IS NOT REMOVED WELL ENOUGH, POOLS IN THE WOUND AND THAT THE SURROUNDING SKIN GETS MACERATED AND THE FILM COMES LOOSE. IN SEVERAL CASES THE ALARM WAS NOT TRIGGERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290924 RENASYS GO NPWT DEVICE PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) BTA SMITH & NEPHEW WOUND MANAGEMENT 66800164 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1