BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS EZPLUS CANISTER 800ML

    MDR report key: 3763931 · Received April 22, 2014

    Report

    Report Number
    3006760724-2014-00228
    Event Type
    Malfunction
    Date Received
    April 22, 2014
    Date of Event
    May 7, 2012
    Report Date
    April 21, 2014
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    BTA
    PMA / PMN Number
    K082426
    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. (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 EZPLUS CANISTER 800ML. THE COMPLAINT WAS CONFIRMED UPON THE EVALUATION OF RETURNED SAMPLES AND PHOTOGRAPHIC EVIDENCE. THE ROOT CAUSE WAS IDENTIFIED FROM (B)(4) AS HIGH CONCENTRATION OF PLASTICIZER MIGRATING FROM THE PVC TUBING ONTO THE CANISTER LID PORT AND SOFTENING THE MOLDED FEATURES. THE VARIATION OF PLASTICIZER CONTENT MAKES SOME OF THE SAME LOT CANISTERS EXHIBIT THE SOFTENING AT VARIOUS DEGREES, FROM MILD TO EXTREME DEFORMATION THAT INCLUDES COMPLETE DETACHMENT OF THE FILTER TUBING IN SOME CASES. THE REVIEW OF THE MANUFACTURING RECORDS INDICATE THAT THE FIRST LOT TO POTENTIALLY HAVE THIS INTERACTION IS LOT M400054 AS IT INTRODUCED THE UNIQUE COMBINATION OF NEW CANISTER LID MATERIAL WITH SAME EXISTING PVC TUBING. OTHER SIMILAR COMPLAINTS HAVE BEEN REPORTED FOR SIMILAR EVENT WHERE THE TUBING EITHER COMES DETACHED IN PACKAGE OR IT LOOKS LIKE THE CANISTER PORT IS ELONGATED AND DEFORMED. . SMITH & NEPHEW CONDUCTED A 100% INSPECTION AT DISTRIBUTION TO SORT AND DISCARD THE DEFECTIVE CANISTERS, AS AN IMMEDIATE CORRECTIVE ACTION OF THE PROBLEM, WHILE IMPLEMENTING THE NEW PVC TUBING BY THE MANUFACTURER. AN ANALYSIS OF THE CHEMICAL REACTION SUGGESTED THE CORRECTION (NEW PVC TUBING WITH LESS PLASTICIZER) THAT HAS BEEN SUCCESSFULLY IMPLEMENTED SINCE EARLY APRIL 2012 UNDER (B)(4) AND VERIFIED UNDER (B)(4). IN RESPONSE TO THIS COMPLAINT AND OTHERS, THE PVC MATERIAL HAS BEEN REPLACED FOR ONE WITH REDUCED AMOUNT OF PLASTICIZER IN THE ASSEMBLY OF CANISTERS SINCE LOT # M400141, WHICH HAVE BEEN VERIFIED VISUALLY TO CORRECTLY ADDRESS THE ISSUE. SMITH & NEPHEW HAS ISSUED CAR02714 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 LEAKING AND THE ALARM ON THE RENASYS EZ PLUS DID NOT TRIGGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241868 RENASYS EZPLUS CANISTER 800ML PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) BTA SMITH & NEPHEW WOUND MANAGEMENT 66800912 M400096

    Patients

    Seq Age Sex Outcome Treatment
    1 Other