BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENASYS GO NPWT DEVICE

    MDR report key: 2833399 · Received November 15, 2012

    Report

    Report Number
    3006760724-2012-00012
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 16, 2012
    Report Date
    March 19, 2013
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    BTA
    PMA / PMN Number
    K083375
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SMITH & NEPHEW HAS COMPLETED THEIR INVESTIGATION INTO THIS EVENT. THE INVESTIGATION WAS LIMITED AS NO DEVICE WAS RETURNED, AND NO SERIAL NUMBER WAS PROVIDED. THEREFORE A REVIEW OF THE DESIGN HISTORY FILE COULD NOT BE PERFORMED, AND THE DEVICE WAS NOT AVAILABLE FOR TESTING. THE PATIENT DID ALLOW FOR A RELEASE OF MEDICAL RECORDS TO SMITH & NEPHEW, HOWEVER THE RECORDS OBTAINED DID NOT PROVIDE ANY INDICATION AS TO WHAT MAY HAVE CAUSED THE REPORTED INFECTION. OUR MEDICAL ADVISOR REVIEWED THE DETAILS CONTAINED IN THE INITIAL REPORT ALONG WITH THE MEDICAL RECORDS, AND MADE THE FOLLOWING ASSESSMENT: THIS PATIENT HAD AN OPERATIVE PROCEDURE AND THEN A WOUND THAT WAS TREATED WITH RENASYS NPWT. ORDINARILY AN ELECTIVE PROCEDURE WITH NO INFECTION WOULD BE MANAGED WITH WOUND CLOSURE AND NPWT WOULD NOT BE USED. IN THE CASE OF ANY WOUND CONTAMINATION, OFTEN THE WOUND IS LEFT OPEN AND NPWT CAN BE USED TO AID IN SECONDARY HEALING WHEN THERE ARE NO SIGNS OF INFECTION. IT IS NOT CLEAR FROM THE INFORMATION PROVIDED WHAT THE NATURE OF THE OPERATION WAS THAT RESULTED IN THE USE OF NPWT. AT ANY RATE, THE DEVELOPMENT OF AN INFECTION IN THIS WOUND IN THIS TIME FRAME WOULD NOT BE THAT UNUSUAL, AND IT WOULD NOT BE RELATED TO THE USE OF NPWT. IN MY OPINION, ANY WOUND THAT IS BEING TREATED WITH NPWT THAT DEVELOPS SIGNS OF INFECTION SHOULD HAVE THE NPWT DISCONTINUED AND ALTERNATIVE DRESSINGS INITIATED. THERE IS NO BASIS TO ASSERT THAT THE INFECTION IN THIS CASE WAS CAUSED BY OR RELATED IN ANY WAY TO THE RENASYS NPWT. BASED ON OUR INVESTIGATION, AND THE REVIEW OF THIS INCIDENT BY OUR MEDICAL ADVISOR WE CONCLUDED THAT THE NEGATIVE PRESSURE SYSTEM PERFORMED AS EXPECTED, AND A DEVICE FAILURE COULD NOT BE CONFIRMED AS HAVING POTENTIALLY CAUSED OR CONTRIBUTED TO THE EVENT REPORTED. AS A CONDITION OF USE, THE RENASYS DEVICE SHOULD ONLY BE USED BY QUALIFIED AND AUTHORIZED PERSONNEL. THE USER MUST HAVE THE NECESSARY KNOWLEDGE OF THE SPECIFIC MEDICAL APPLICATION FOR WHICH NPWT IS BEING USED, AND MAINTAIN REGULAR MONITORING OF THE RENASYS DEVICE AND WOUND SITE DURING THERAPY TO ENSURE THERAPEUTIC TREATMENT AND PATIENT COMFORT. THE RENASYS INSTRUCTIONS FOR USE INDICATE THAT THE SMITH & NEPHEW RENASYS NPWT SYSTEM IS INDICATED FOR PATIENTS WHO WOULD BENEFIT FROM A SUCTION DEVICE (NEGATIVE PRESSURE WOUND THERAPY) AS IT MAY PROMOTE WOUND HEALING VIA THE REMOVAL OF FLUIDS INCLUDING IRRIGATION AND BODY FLUIDS, WOUND EXUDATES AND INFECTIOUS MATERIALS. EXAMPLES OF APPROPRIATE WOUND TYPES INCLUDE: CHRONIC, ACUTE, TRAUMATIC, SUB-ACUTE AND DEHISCED WOUNDS, ULCERS (SUCH AS PRESSURE OR DIABETIC), PARTIAL-THICKNESS BURNS, FLAPS AND GRAFTS. THE USE OF NPWT IS CONTRAINDICATED FOR: UNTREATED OSTEOMYELITIS, EXPOSED ARTERIES, VEINS, ORGANS OR NERVES, NECROTIC TISSUE WITH ESCHAR PRESENT, MALIGNANCY IN THE WOUND (WITH EXCEPTION OF PALLIATIVE CARE TO ENHANCE QUALITY OF LIFE), NON-ENTERIC AND UNEXPLORED FISTULAS, OR ANASTOMOTIC SITES. THE FOLLOWING WARNINGS AND PRECAUTIONS ARE ALSO NOTED IN THE INSTRUCTIONS FOR USE: CAREFULLY MONITOR PATIENTS FOR SIGNS OF SUDDEN OR INCREASED BLEEDING. IF SUCH SYMPTOMS ARE OBSERVED, IMMEDIATELY DISCONTINUE THERAPY, TAKE APPROPRIATE MEASURES TO CONTROL THE BLEEDING, AND CONTACT THE TREATING CLINICIAN. PATIENTS SUFFERING FROM DIFFICULT HEMOSTASIS OR WHO ARE RECEIVING ANTICOAGULANT THERAPY HAVE AN INCREASED RISK OF BLEEDING. DURING THERAPY, AVOID USING HEMOSTATIC PRODUCTS THAT, IF DISRUPTED, MAY INCREASE THE RISK OF BLEEDING. DO NOT USE ON EXPOSED BLOOD VESSELS OR ORGANS. SHARP EDGES SUCH AS BONE FRAGMENTS MUST BE COVERED OR REMOVED PRIOR TO INITIATING THERAPY, DUE TO RISK OF PUNCTURING ORGANS OR BLOOD VESSELS DRAWN CLOSER UNDER THE ACTION OF NEGATIVE PRESSURE. PRECAUTIONS SHOULD BE TAKEN FOR PATIENTS WHO ARE OR MAY BE: RECEIVING ANTICOAGULANT THERAPY OR PLATELET AGGREGATION INHIBITORS, ACTIVELY BLEEDING OR HAVE FRIABLE BLOOD VESSELS OR ORGANS, SUFFERING FROM ABNORMAL WOUND HEMOSTASIS, UNTREATED FOR MALNUTRITION, NONCOMPLIANT OR COMBATIVE, SUFFERING FROM WOUNDS IN CLOSE PROXIMITY TO BLOOD VESSELS OR FRIABLE FASCIA. IN ADDITION, THE DRESSING CHANGE INSTRUCTIONS INDICATE RENASYS. FOAM DRESSINGS SHOULD BE CHANGED EVERY 48-72 HOURS AFTER THE INITIAL APPLICATION OF THERAPY. IF NO LEAK IS PRESENT AND THE PATIENT IS COMFORTABLE, DRESSING CHANGES SHOULD OCCUR NO LESS THAN 3 TIMES PER WEEK. RENASYS GAUZE DRESSINGS SHOULD BE CHANGED 48 HOURS AFTER THE INITIAL APPLICATION OF THERAPY. IF NO LEAK IS PRESENT AND THE PATIENT IS COMFORTABLE, DRESSING CHANGES SHOULD OCCUR 2-3 TIMES PER WEEK. CHECK THE DRESSING REGULARLY. THROUGHOUT TREATMENT, MONITOR THE PATIENT FOR ANY SIGNS OF LOCAL OR SYSTEMIC INFECTION. INFECTED WOUNDS MAY REQUIRE MORE FREQUENT DRESSING CHANGES. IF THERE ARE ANY SIGNS OF SYSTEMIC INFECTION OR ADVANCING INFECTION AT THE WOUNDED AREA, CONTACT THE TREATING CLINICIAN IMMEDIATELY. NO FURTHER INVESTIGATION OR CORRECTIVE ACTIONS WILL BE CONDUCTED AT THIS TIME. SMITH & NEPHEW WILL CONTINUE TO MONITOR THE COMPLAINTS SYSTEM AND OTHER POST MARKET SURVEILLANCE SOURCES FOR SIMILAR REPORTS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PATIENT WAS TREATED (POST-OPERATIVE PROCEDURE) WITH RENASYS NPWT IN HOSPITAL FOR 5 DAYS. CUSTOMER CONTINUED NPWT TREATMENT AT HOME WITH VISITING NURSES CHANGING HER DRESSINGS DAILY. CUSTOMER BEGAN TO HAVE PAIN AND OTHER SYMPTOMS OF SICKNESS. SHE RETURNED TO THE HOSPITAL WHERE SHE SPENT 3 WEEKS RECEIVING IV ANTIBIOTICS, MORPHINE AND OTHER PAIN MEDS. AN INFECTION WAS DETERMINED TO BE THE CAUSE AND IT HAD SPREAD THROUGH HER BODY, IMPACTING AN AREA OF HER LEG. SURGERY WAS PERFORMED TO REMOVE A PORTION OF THE BACK OF HER LEG AND PART OF HER KNEE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O