BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS EZ/EZ PLUS CANISTER 800 ML

    MDR report key: 3761061 · Received April 21, 2014

    Report

    Report Number
    3006760724-2014-00182
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    October 3, 2012
    Report Date
    April 11, 2014
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    BTA
    PMA / PMN Number
    K102001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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: (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 EZ PLUS CANISTER 800 ML. THIS COMPLAINT INVOLVES CANISTERS NOT CAUSING ALARMS WHEN VISIBLY FULL. THE COMPLAINT IS CONFIRMED AS THE ALARM COULD NOT BE READILY OBSERVED AFTER SUCCESSFUL NEGATIVE PRESSURE THERAPY AND FULL CANISTER UTILIZATION. THE ROOT CAUSE OF A FULL CANISTER NOT TRIGGERING A PUMP ALARM WAS THE FIT OF CONFORMING ANTIMICROBIAL FILTERS INTO THE EZ OR EZ PLUS PUMP (SAME ORIFICE DESIGN AND TOLERANCES). IN ALL CASES, FULL INSERTION WAS NOT REQUIRED TO OBTAIN PROPER NEGATIVE PRESSURE AND INFLOW TO CANISTERS. THE COMPLAINT AGAINST THE 250CC CANISTERS IS BETTER UNDERSTOOD TO CAUSE PROBLEMS IN MONITORING CANISTER VOLUMES COMPARED TO THE 800CC CANISTER AS THE CANISTER HOLDER COVERS MOST OF THE CANISTER BODY AND GRADUATIONS. MOST USERS WOULD NOT RELY ON THE ALARM TO REPLACE THE CANISTERS, BUT FOR SOME USERS THE ALARM IS EXPECTED TO INDICATE A CANISTER HAS BEEN FULLY OCCUPIED BY EXUDATES AND SUCTION OCCLUDED BY RESULTING GEL MATERIAL. PUMP ALARM MUST NOT REPLACE CLINICAL MONITORING. OUR RECOMMENDATIONS FOR PUMP USE INDICATE REPLACEMENT OF CANISTERS WHEN 2/3 FULL, AND FROM WHAT IS REPORTED, THE USAGE IS EXTENDED BEYOND THIS RECOMMENDED SAFE LEVEL BEFORE REPLACEMENT. REVIEW FOR SAFETY INDICATED THAT THE COMPLETELY-FULL CANISTERS ARE SEALING SHUT FROM SOLIDIFIER AND OVERFLOW PROTECTION, AND VACUUM IS HELD ENOUGH TO PREVENT BACKFLOW INTO WOUND SITE. SINCE THE ONLY CIRCUMSTANCES FOR REPEAT COMPLAINTS WOULD BE FOR CLINICIANS WAITING FOR AN ALARM TO REPLACE THE CANISTERS, IT IS ADVISED TO FULLY INSERT THE FILTER INTO PUMP AND MONITOR CANISTER VOLUMES CLOSELY IN SYSTEM USE. 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: DRESSING WAS COMPRESSED, BUT CANISTER WAS FULL AND NO FULL ALARM NOTED ON THE RENASYS EZ PLUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240405 RENASYS EZ/EZ PLUS CANISTER 800 ML PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) BTA SMITH & NEPHEW WOUND MANAGEMENT 66800912 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other