BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS F MEDIUM WITH SOFT PORT

    MDR report key: 3757535 · Received April 17, 2014

    Report

    Report Number
    3006760724-2014-00134
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    September 28, 2012
    Report Date
    April 14, 2014
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    BTA
    PMA / PMN Number
    K110647
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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: 3006160724. 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 F MEDIUM WITH SOFT PORT. SMITH & NEPHEW RECEIVED THE ABOVE REPORTED COMPLAINT FOR FAILURE TO ALARM. NO SAMPLES, PICTURES OR LOT NUMBER INFORMATION WERE PROVIDED FOR EVALUATION. THE RENASYS SYSTEM PROVIDES BLOCKAGE DETECTION IF THERE IS A BLOCKAGE TO AIR FLOW SUCTIONED INTO THE PUMP FROM SYSTEM CONNECTIONS THAT INCLUDE AT LEAST A CANISTER AND THE WOUND DRESSING. THE PUMP BY ITSELF ALARMS TO BLOCKAGE/CANISTER FULL IF IN THE RANGE OF 0.0 L/MIN-0.05 L/MIN FOR WHICH THE PUMP MOTOR OPERATION DRIVES THE ALARM ELECTRONICALLY. THE PUMP OPERATES NORMALLY FOR LEAK RATES UP TO A RANGE OF 2.5 -3.5 L/MIN BUT IS DESIGNED TO ALARM FOR EXCESSIVE LEAK IF TRIGGERED BY PRESSURE DIFFERENTIALS BETWEEN PRESSURE SELECTOR SETTING AND THE SUSTAINED PRESSURE MEASURED ON GAUGE, REACTING AS AN INDICATION THAT THE DESIRED SUSTAINED PRESSURE IS NOT STABLE DUE TO A LEAK. IN SUMMARY, THE PUMP IN SYSTEM CONNECTION WILL BE SENSITIVE TO LEAK RATES BELOW 0.05 L/MIN AND TO INSTABILITY IN PRESSURE HELD FOR SYSTEM WHEN NEGATIVE PRESSURE CANNOT BE SUSTAINED WITHIN 25MMHG OF SETTING. 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 PARTIAL OCCLUSION IN SOFT PORT. THIS ISSUE HAS BEEN CONFIRMED. (B)(4) HAS BEEN INITIATED TO FURTHER INVESTIGATE THE ROOT CAUSES FOR FAILURES OF THIS TYPE, AND DRIVE ANY POTENTIAL CORRECTIVE ACTIONS.AS A RESULT OF SIMILAR COMPLAINTS 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: CUSTOMER REPORTING MULITPLE INSTANCES OF POOLING IN THE WOUND BED AND ALARM NOT GOING OFF WHEN LEAK WAS VISUALLY PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234969 RENASYS F MEDIUM WITH SOFT PORT PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) BTA SMITH & NEPHEW WOUND MANAGEMENT 66800795 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other