BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVIA CENTAUR

    MDR report key: 1843447 · Received September 22, 2010

    Report

    Report Number
    2432235-2010-00130
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    June 1, 2010
    Report Date
    September 1, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K971418
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE SINK EXPLOSION IS UNKNOWN. THIS EVENT WAS REPORTED TO SIEMENS APPROXIMATELY TWO (2) MONTHS AFTER THE INCIDENT OCCURRED. UPON LEARNING OF THE INCIDENT, A SIEMENS TECHNICAL SERVICE CENTER SPECIALIST CONTACTED THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION REGARDING THE INJURIES SUSTAINED BY THE MAINTENANCE WORKER. IN ADDITION, THE CUSTOMER WAS PROVIDED WITH MSDS SHEETS. THE INSTRUCTIONS FOR USE FOR SIEMENS REAGENTS THAT CONTAIN SODIUM AZIDE CLEARLY STATE, "SODIUM AZIDE CAN REACT WITH COPPER AND LEAD PLUMBING TO FORM EXPLOSIVE METAL AZIDES. IF DISPOSAL INTO A DRAIN IS IN COMPLIANCE WITH FEDERAL, STATE AND LOCAL REQUIREMENTS, FLUSH REAGENTS WITH A LARGER AMOUNT OF WATER TO PREVENT BUILDUP OF AZIDES." NO FURTHER EVALUATION IS REQUIRED.

    Description of Event or Problem · 1

    A MAINTENANCE WORKER WAS INJURED IN THE PROCESS OF REPLACING A SINK AT A CUSTOMER SITE. THE CUSTOMER RAISED THE POSSIBILITY THAT A BUILD UP OF SODIUM AZIDE IN THE PIPES (CAUSED BY REAGENT WASTE BEING POURED DOWN THE DRAIN) MAY HAVE BEEN A CONTRIBUTING FACTOR FOR THE EXPLOSION. THE MAINTENANCE WORKER WAS TREATED AT AN EMERGENCY ROOM AND CONTINUES TO BE SEEN FOR HIS INJURIES. NOTE: INSTRUMENTS IDENTIFIED AT THE CUSTOMER SITE INCLUDE SIEMENS ADVIA CENTAUR (B)(4), ADVIA 1800 (B)(4), ADVIA WORKCELL AND BECKMAN COULTER LH-50.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR IMMUNOASSAY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS ADVIA CENTAUR NA

    Patients

    Seq Age Sex Outcome Treatment
    1