BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRENASYS G MEDIUM W/SOFT PORT

    MDR report key: 3757081 · Received April 17, 2014

    Report

    Report Number
    3006760724-2014-00125
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    August 15, 2012
    Report Date
    April 15, 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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SMITH & NEPHEW RECEIVED THE ABOVE REPORTED COMPLAINT FOR FAILURE TO ALARM. NO SAMPLES OR PICTURES WERE PROVIDED; HOWEVER, THE KIT LOT NUMBER WAS PROVIDED. REGARDING DRESSING DETACHED FROM PATIENT, A REASONABLE EXPLANATION COULD BE THAT THE DRESSING BECAME DETACHED DUE TO THE LOCATION OF THE WOUND. COMPLAINT DESCRIPTION INCLUDES THAT WOUND LOCATION WAS THE SACRAL AREA. REGARDING PUMP NOT LEAK ALARMING, 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 PUMP 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. 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 AS REPORTED, AND CANISTER WAS RECEIVING A SMALLER VOLUME DUE TO PARTIAL OCCLUSION IN SOFT PORT. THIS IS SUPPORTED BY THE COMPLAINT DESCRIPTION WHERE IT MENTIONS THAT SOFT PORT WAS ¿STILL COMPRESSED AND PULLING FLUID¿ AFTER LIFTING ON ONE SIDE FROM WOUND. THIS ISSUE HAS BEEN CONFIRMED. WE WISH TO ASSURE YOU WE HAVE GIVEN THIS MATTER OUR FULL ATTENTION AND WILL CONTINUE TO MONITOR FOR THIS TYPE OF COMPLAINT. THE COMPLAINT IS RECORDED AND ANY SIMILAR ISSUES WILL BE MONITORED THROUGH THE COMPLAINT SYSTEM. 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: LACK OF LEAK ALARM AFTER DRESSING LIFT. THE PUMP WAS ON AND RUNNING, BUT WAS NOT SIGNALING A LEAK ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234562 PRENASYS G MEDIUM W/SOFT PORT PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) BTA SMITH & NEPHEW WOUND MANAGEMENT 66800934

    Patients

    Seq Age Sex Outcome Treatment
    1 Other