BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 1276487 · Received December 31, 2008

    Report

    Report Number
    1276487
    Event Type
    Injury
    Date Received
    December 31, 2008
    Date of Event
    April 2, 2008
    Report Date
    December 31, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US

    Narratives

    Description of Event or Problem · 1

    CAUSTIC CHEMICALS ACCUMULATED IN THE SINK DRAIN PIPE DUE TO LACK OF FLUSHING WITH ADEQUATE AMOUNTS OF WATER. WHEN TRYING TO MOVE THE SINK AND DISCONNECT THE DRAIN, THE ACTIVITY WAS ENOUGH TO STIMULATE A CHEMICAL REACTION BETWEEN THE SODIUM AZIDE IN THE CHEMICALS AND THE COPPER PIPE RESULTING IN COPPER AZIDE, WHICH IS EXPLOSIVE. THE LAB AND MAINTENANCE STAFF WERE UNAWARE OF THIS POSSIBILITY WHEN THE METAL PIPE WAS INSTALLED A FEW YEARS AGO TO ACCOMMODATE OUR NEW EQUIPMENT. WE DID NOT CHECK THE MSDS, AND THE VENDOR WAS INCONSISTENT IN ITS APPROACH TO INSTALLATION AND INFORMING ITS CUSTOMERS OF THE POTENTIAL HAZARDS, I.E. THE SERVICE REP WAS UNAWARE THAT THIS INSTRUMENT USED A SOLUTION CONTAINING AZIDES. THIS HOWEVER, DOES NOT RELEASE THE LAB FROM CHECKING THE MSDS. IT IS ULTIMATELY OUR RESPONSIBILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * ANALYZER, COAGULATION JJF BECKMAN COULTER, INC. ACL-TOP *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other| R NO OTHER THERAPIES| NO OTHER THERAPIES