BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM

    MDR report key: 3130768 · Received May 24, 2013

    Report

    Report Number
    1226181-2013-00242
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE CUSTOMER EXPLAINED THAT THE DIMENSION VISTA 1500 WASTE LINES HAD BEEN RE-ROUTED BY THE CONSTRUCTION COMPANY. THE LINES BEGAN TO LEAK, AND THE CONSTRUCTION WORKERS WERE EXPOSED TO THE BIOHAZARDOUS FLUID WHEN THEY ATTEMPTED TO ADDRESS THE LEAK. THE CSE DISCOVERED THAT THE WASTE LINES WERE NOT SECURED ADEQUATELY AND RE-SECURED THE WASTE LINES. THE OPERATOR'S GUIDE FOR DIMENSION VISTA INSTRUMENTS STATES, "MAINTENANCE OF THE WASTE TUBING FROM THE INSTRUMENT TO THE DISPOSAL POINT IS THE RESPONSIBILITY OF THE OPERATOR." THE CAUSE OF THE EXPOSURE TO BIOHAZARDOUS FLUID WAS A LEAK IN THE WASTE LINES DUE TO THE WASTE LINES BEING INADEQUATELY SECURED. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    FOUR CONSTRUCTION WORKERS WERE EXPOSED TO BIOHAZARDOUS WASTE FROM A DIMENSION VISTA 1500 INSTRUMENT. THE CONSTRUCTION WORKERS WERE WEARING GLOVES, BUT THEIR ARMS WERE EXPOSED TO THE BIOHAZARDOUS FLUID. THE CONSTRUCTION WORKERS WASHED THEIR ARMS AND THEN WENT TO THE HOSPITAL EMERGENCY ROOM FOR BASELINE BLOOD TESTING DUE TO THE BIOHAZARD EXPOSURE. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE EXPOSURE TO BIOHAZARDOUS WASTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231981 DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM CLINICAL CHEMISTRY SYSTEM JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 1500

    Patients

    Seq Age Sex Outcome Treatment
    1