BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS EZ PLUS

    MDR report key: 3851280 · Received June 5, 2014

    Report

    Report Number
    3006760724-2014-00371
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    February 17, 2014
    Report Date
    July 14, 2014
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    BTA
    PMA / PMN Number
    K102001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACTIVE INVESTIGATION IN PROGRESS; RESULTS OF INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENT REPORT.

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT WAS CONFIRMED. A TECHNICAL EVALUATION OF THE RETURNED PUMP CONDUCTED AT (B)(6) ON 22 MAY 2014 CONFIRMED DEVICE FAILED LEAK TEST (STEP 8.6) AND HIGH FLOW VACUUM TEST (STEP 8.8) PER (B)(4). A DEFECTIVE MAIN ANALOG CONTROL PC BOARD WAS RULED AS THE AS THE MOST PROBABLE ROOT CAUSE. REVIEW OF COMPLAINTS HISTORY FOR RENASYS EZ PLUS PUMP SERIAL # (B)(4) INDICATES NO OTHER ISSUES HAVE BEEN REPORTED AGAINST THIS DEVICE. REVIEW OF THE RISK ANALYSIS FILE FOR RENAZYZ EZ DETERMINED ALL RESIDUAL RISKS FOR THE POTENTIAL HARMS POSSIBLY ASSOCIATED WITH THIS EVENT HAVE BEEN MITIGATED TO ACCEPTABLE LEVELS. NO FURTHER ACTION IS NECESSARY. THE INFORMATION PROVIDED CONFIRMS THERE WERE NO PATIENT INJURIES OR HARM ASSOCIATED WITH THIS ISSUE. THE COMPLAINT IS RECORDED AND ANY SIMILAR ISSUES WILL BE MONITORED THROUGH THE COMPLAINT SYSTEM.

    Description of Event or Problem · 1

    FAILURE TO ALARM. THE MALE PATIENT HAS 2 WOUNDS, THE FIRST IS A PERINEAL WOUND EXTENDING FROM ABOVE THE PENIS DOWN AND AROUND THE SCROTUM WHICH WAS Y CONNECTED TO A RECTAL WOUND. THE SOFT PORT WAS THEN BRIDGED TO THE UPPER LEG. THE RECTAL WOUND HAD AN OBVIOUSLY COMPROMISED DRESSING BUT THE PUMP DID NOT ALARM. PART OF THE RECTAL DRESSING AND THE BRIDGE REMAINED COMPRESSED DESPITE THE LEAK. AFTER THE INCIDENT I DISCUSSED CONSIDERATIONS TO BE TAKEN, ESPECIALLY WHEN USING A Y CONNECTOR AND THE IMPORTANCE OF TEACHING STAFF TO VISUALIZE THE DRESSING EVERY 2 HOURS WHEN TURNING THE PATIENT, TO ENSURE THERE ARE NO LEAKS AND THERAPY IS BEING DELIVERED. ONCE A NEW DRESSING WAS APPLIED THE FOAM WAS FULLY COMPRESSED AND THE NURSE WAS SATISFIED. THERE WAS NO DETERIORATION OF THE WOUND OR HARM DONE TO THE PATIENT. LATER, AFTER THE PUMP WAS REMOVED FROM THE PATIENT, IT WAS TESTED AND FAILED THE LEAK ALARM TEST.

    Description of Event or Problem · 1

    FAILURE TO ALARM. THE MALE PATIENT HAS 2 WOUNDS, THE FIRST IS A PERINEAL WOUND EXTENDING FROM ABOVE THE PENIS DOWN AND AROUND THE SCROTUM WHICH WAS Y CONNECTED TO A RECTAL WOUND. THE SOFT PORT WAS THEN BRIDGED TO THE UPPER LEG. THE RECTAL WOUND HAD AN OBVIOUSLY COMPROMISED DRESSING BUT THE PUMP DID NOT ALARM. PART OF THE RECTAL DRESSING AND THE BRIDGE REMAINED COMPRESSED DESPITE THE LEAK. AFTER THE INCIDENT I DISCUSSED CONSIDERATIONS TO BE TAKEN, ESPECIALLY WHEN USING A Y CONNECTOR AND THE IMPORTANCE OF TEACHING STAFF TO VISUALIZE THE DRESSING EVERY 2 HOURS WHEN TURNING THE PATIENT, TO ENSURE THERE ARE NO LEAKS AND THERAPY IS BEING DELIVERED. ONCE A NEW DRESSING WAS APPLIED THE FOAM WAS FULLY COMPRESSED AND THE NURSE WAS SATISFIED. THERE WAS NO DETERIORATION OF THE WOUND OR HARM DONE TO THE PATIENT. LATER, AFTER THE PUMP WAS REMOVED FROM THE PATIENT, IT WAS TESTED AND FAILED THE LEAK ALARM TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330147 RENASYS EZ PLUS PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) BTA SMITH & NEPHEW WOUND MANAGEMENT 66800697

    Patients

    Seq Age Sex Outcome Treatment
    1