BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEMIS 1200CC HIFLOW SUCTION CANISTER

    MDR report key: 3823211 · Received February 27, 2014

    Report

    Report Number
    2133713-2014-00006
    Event Type
    Malfunction
    Date Received
    February 27, 2014
    Date of Event
    January 30, 2014
    Report Date
    February 27, 2014
    Manufacturer
    BEMIS MFG. CO.
    Product Code
    GCX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN RARE INSTANCES, THE FLOAT MECHANISM THAT PREVENTS FLUID FROM ENTERING THE VACUUM SYSTEM WHEN THE CANISTER IS FILLED MAY BECOME STUCK IN THE CLOSED POSITION IN SHIPPING OR STORAGE. THIS WILL PREVENT VACUUM FROM BUILDING IN THE CANISTER. WHILE A PERMANENT CORRECTIVE ACTION IS BEING INVESTIGATED, WE ARE ADVISING CUSTOMERS TO CHECK OUT THE CANISTER PRIOR TO USE, AND ADVISING A METHOD TO FREE THE FLOAT. NOTIFICATION LETTER TO OUR CUSTOMERS, A LEAFLET INCLUDED WITH THE PRODUCT, AND THE RESULTS OF OUR INVESTIGATION ARE INCLUDED WITH THIS REPORT.

    Description of Event or Problem · 1

    COMPLAINANT STATES THEY ARE HAVING RECURRENT ISSUES WITH THE VACUUM SHUTOFF VALVE STUCK IN THE UPPER OR OFF POSITION WHEN SETTING UP THE CANISTER. WHEN THAT OCCURS, THERE IS NO SUCTION IN THE CANISTER. STAFF MUST REMOVE THE VACUUM SOURCE AND TAP THE CANISTER COVER TO ENABLE THE VALVE TO DROP TO THE LOWER OR ON POSITION. THERE WAS NO PT INVOLVEMENT IN ANY OF THE INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122757 BEMIS 1200CC HIFLOW SUCTION CANISTER APPARATUS, SUCTION, VACUUM POWERED GCX BEMIS MFG. CO. 484410 20131206

    Patients

    Seq Age Sex Outcome Treatment
    1