BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS GO NEGATIVE PRESSURE WOUND THERAPY DEVICE

    MDR report key: 3759546 · Received April 18, 2014

    Report

    Report Number
    3006760724-2014-00170
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    June 20, 2013
    Report Date
    April 9, 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 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. (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 A PUMP MALFUNCTION. AN EVALUATION WAS CONDUCTED TO THE DEVICE AND NO PROBLEM WAS FOUND. THE SYSTEM DEFINES A BLOCKAGE ALARM AS A SUSTAINED AIR FLOW OF LESS THAN 0.050L/MIN @80MMHG, EXCEEDING THE 5 MINUTES AND THE LEAKAGE ALARM IT IS DEFINED AS SUSTAINED AIR FLOW IN EXCESS OF 3.5L/MIN @80MMHG FOR MORE THAN 3 MINUTES. A LEAK ALARM WILL NOT BE ASSERTED UNTIL FLUID HAS CLEARED THE TUBING SET AND AIR HAS BEEN FREELY FLOWING THROUGH THE TUBING AT A RATE GREATER THAN 3.5L/MIN @80MMHG. THERE WAS DRAINAGE DETECTED AT THE CANISTER CONFIRMING THAT THE SYSTEM WAS HOLDING THE NEGATIVE PRESSURE CONTINUOUSLY. IT IS POSSIBLE THAT WITH THICKENED EXUDATE IN THE TUBING, AIR FLOW WILL NOT EXCEED THE 3.5 L/MIN. ONCE THE DRAPE AND DRESSING WERE LIFTED AND AIR WAS FLOWING IN EXCESS OF 3.5L/MIN AN ALARM WAS TRIGGERED BY THE SYSTEM; CONFIRMED WITHIN THE REPORTED COMPLAINT. A POSSIBLE ROOT CAUSE IS THAT IN THE NORMAL OPERATION OF THE SOFT PORT, DRESSING ABSORBED EXUDATES THAT SLOWED DOWN THE TRANSPORT OF FRESHLY PULLED EXUDATES IN SYSTEM. IN THAT CIRCUMSTANCE THE PUMP MAINTAINED NEGATIVE PRESSURE AND CANISTER WAS RECEIVING A SMALLER VOLUME DUE TO A PARTIAL OCCLUSION IN SOFT PORT. THE DEVICE IS WORKING WITHIN SPECIFICATIONS. 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: APPROXIMATELY 48 HOURS AFTER INITIAL DRESSING APPLIED IT BECAME LOOSE AND THERE WAS NO LEAK OR BLOCKAGE ALARM ON THE RENASYS GO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237389 RENASYS GO NEGATIVE PRESSURE WOUND THERAPY DEVICE PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) BTA SMITH & NEPHEW WOUND MANAGEMENT WD66800164 KGVE130061

    Patients

    Seq Age Sex Outcome Treatment
    1 Other