BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS GO NEGATIVE PRESSURE WOUND THERAPY DEVICE

    MDR report key: 3759552 · Received April 18, 2014

    Report

    Report Number
    3006760724-2014-00163
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    December 12, 2012
    Report Date
    April 11, 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
    CA, 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 GO NEGATIVE PRESSURE WOUND THERAPY DEVICE. THE COMPLAINT WAS NOT CONFIRMED, AS THE DEVICE WAS NOT AVAILABLE FOR EVALUATION WITHIN A REASONABLE TIME FRAME FOR THE CLOSURE OF THE COMPLAINT. THE COMPLAINT INVOLVES AN ADVERSE EVENT FOR A PATIENT BEING TREATED FOR DIABETIC FOOT ULCER RESULTING FROM A CALLUS HE REMOVED. PATIENT EXPERIENCED MACERATED FOOT AFTER NEGATIVE PRESSURE WOUND THERAPY APPLIED. THE APPLICATION TECHNIQUE WAS REVIEWED FOR THE PATIENT. SKIN PROTECTANT AND PERI-WOUND SKIN DRAPED WITH DRESSING, FOAM APPLIED INTO WOUND DEFICIT, AND ENTIRE WOUND AND SURROUNDING SKIN DRAPED PER PROTOCOL. WOUND BRIDGED TO TOP OF FOOT WITH FOAM TOUCHING, 2 CM HOLE CUT INTO BRIDGE FOAM, AND PORT ATTACHED. SUCTION WAS APPLIED AT -120MMHG. THE DRESSING WAS CHANGED, AND NO DRAINAGE NOTED IN CANISTER. FOAM WET, SKIN PERI- WOUND WHITE COLOR FROM SKIN MACERATION. RN SUSPECTS PUMP NOT WORKING PROPERLY AND WAS INSTRUCTED TO CALL APRIA TO HAVE PUMP EXCHANGED FOR NEW ONE. NEGATIVE PRESSURE WOUND THERAPY WAS NOT APPLIED THE FOLLOWING DAY TO ALLOW SKIN TO DRY OUT. THE PUMP HAS ¿UNKNOWN¿ FOR SERIAL NUMBER. GIVEN THE UNKNOWN SERIAL NUMBER, NEITHER A DEVICE HISTORY RECORD FOR THE DEVICE NOR A SERVICE REPORT CAN BE RESEARCHED. THE ASSOCIATED GO CANISTER AND SOFT PORT KIT WERE NOT INCLUDED WITHIN THE COMPLAINT REPORT. SINCE THE NEGATIVE PRESSURE WOUND THERAPY INVOLVES VARIOUS ELEMENTS, IT IS DIFFICULT TO DETERMINE AND ASSIGN A DEFINITIVE ROOT CAUSE FOR THE ISSUE REPORTED WITHIN THE COMPLAINT.

    Description of Event or Problem · 1

    MACERATION: PATIENT IS BEING TREATED FOR DIABETIC FOOT ULCER RESULTING FROM A CALLUS HE REMOVED. PATIENT EXPERIENCED MACERATED FOOT AFTER NEGATIVE PRESSURE WOUND THERAPY APPLIED. SUCTION APPLIED AT -120MMHG. THIS DRESSING CHANGE HAD NO DRAINAGE NOTED IN CANISTER. FOAM WET, SKIN PERI WOUND WHITE COLOR FROM SKIN MACERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237390 RENASYS GO NEGATIVE PRESSURE WOUND THERAPY DEVICE PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) BTA SMITH & NEPHEW WOUND MANAGEMENT 66800164

    Patients

    Seq Age Sex Outcome Treatment
    1 Other