BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS GO NEGATIVE PRESSURE WOUND THERAPY

    MDR report key: 3757539 · Received April 17, 2014

    Report

    Report Number
    3006760724-2014-00136
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    August 23, 2012
    Report Date
    April 14, 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
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SMITH & NEPHEW RECEIVED THE ABOVE PRODUCT COMPLAINT FOR ADVERSE EVENT. NO PICTURES, NO SAMPLES AND NO LOT NUMBER INFORMATION WERE PROVIDED FOR EVALUATION. THE COMPLAINT DESCRIPTION INCLUDES THAT THE WOUND WAS A SACRAL WOUND AND THAT THE DRESSING HAD LIFTED. THE LOCATION OF THE WOUND/DRESSING COULD HAVE PROVEN TO BE CHALLENGING IN MAINTAINING A SEAL. IT WAS LEARNED THAT THE PATIENT¿S BED MOVEMENT MAY HAVE CAUSED DRESSING TO LIFT OF THE WOUND. COMPLAINT INDICATES THAT ONCE DRESSING HAD LIFTED, THERE WAS NO LEAK OR BLOCKAGE ALARMS. 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. 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: APPLIED RENASYS GO NEGATIVE PRESSURE WOUND THERAPY (DIFFERENT PUMP) WITH GAUZE DRESSING AND SOFTPORT. IT WAS NOTICED IN THE MORNING THAT THE DRESSING HAD LIFTED, BUT PROBABLY HAPPENED DURING THE NIGHT, DRAINAGE LEAKING AND MACERATION OCCURRED AROUND THE WOUND. RENASYS GO PUMP WAS STILL RUNNING AT 80MMHG WITH NO LEAKAGE OR BLOCKAGE ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235343 RENASYS GO NEGATIVE PRESSURE WOUND THERAPY PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) BTA SMITH & NEPHEW WOUND MANAGEMENT 66800164

    Patients

    Seq Age Sex Outcome Treatment
    1 Other