BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS EZPLUS CANISTER 800ML

    MDR report key: 3770119 · Received April 24, 2014

    Report

    Report Number
    3006760724-2014-00309
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    November 29, 2012
    Report Date
    April 23, 2014
    Manufacturer
    SMITH AND NEPHEW WOUND MANAGEMENT
    Product Code
    BTA
    PMA / PMN Number
    K102001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    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 IS DEEMED CONFIRMED. THE ROOT CAUSE WAS IDENTIFIED AS HIGH CONCENTRATION OF PLASTICIZER MIGRATING FROM THE PLASTIC 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 TUBING. OTHER SIMILAR COMPLAINTS HAVE SINCE 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 PLASTIC TUBING AT MANUFACTURER. AN ANALYSIS OF THE CHEMICAL REACTION SUGGESTED THE CORRECTION (NEW PLASTIC TUBING WITH LESS PLASTICIZER) THAT HAS BEEN SUCCESSFULLY IMPLEMENTED AND VERIFIED UNDER A PREVENTIVE ACTION REPORT. IN RESPONSE TO THIS COMPLAINT AND OTHERS, THE PLASTIC MATERIAL HAS BEEN REPLACED FOR ONE WITH REDUCED AMOUNT OF PLASTICIZER IN THE ASSEMBLY OF CANISTERS FROM LOT # M400141 ON, WHICH HAVE BEEN VERIFIED VISUALLY TO CORRECTLY ADDRESS THE ISSUE. ANY FUTURE COMPLAINTS RELATED TO THIS ISSUE WILL BE TRACKED AND TRENDED, AND SHOULD A SIGNIFICANT ISSUE OCCURS AFTER THE IMPLEMENTATION OF THE PROCESS IMPROVEMENTS, CORRECTIVE ACTIONS WILL BE TAKEN AT THAT TIME.

    Description of Event or Problem · 1

    PATIENT WAS ON NPWT OVER THE WEEK-END, PUMP WAS NOT MANAGING SUCTION BUT DID NOT ALARM. UPON (B)(6) RETURN TO WORK ON MONDAY, SHE NOTED THAT CANISTER HAD OCCLUDED FILTER TUBING PORT, PLASTIC HAD MELTED. NURSE BELIEVES THAT THIS COMPROMISED THERAPY AND COULD HAVE DELAYED DISCHARGE TO HOME. PATIENT WAS NOT INJURED BUT THERAPY WAS NOT FUNCTIONING WELL DUE TO CANISTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248662 RENASYS EZPLUS CANISTER 800ML PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) BTA SMITH AND NEPHEW WOUND MANAGEMENT 66800912 M400108

    Patients

    Seq Age Sex Outcome Treatment
    1