BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2018749 · Received March 15, 2011

    Report

    Report Number
    1226181-2011-00023
    Event Type
    Injury
    Date Received
    March 15, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 25, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - BROOKFIELD
    Product Code
    JJE
    PMA / PMN Number
    K010061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE WASTE SPLASHING INJURY WAS AN UNUSUAL EVENT. THE CUSTOMER HAD INITIATED A DISCONNECT OF THE INSTRUMENT WASTE LINE PRIOR TO SIEMENS HEALTHCARE DIAGNOSTICS INC. FIELD SERVICE ENGINEER (FSE) INVOLVEMENT. THE CUSTOMER HAD MOVED THE INSTRUMENT FROM USUAL WASTE DRAIN CONNECTIONS. WHEN THE FSE REMOVED THE DISCONNECT FITTING, RESIDUAL PRESSURE IN THE VESTIGIAL WASTE LINE CAUSED THE SPRAY. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A SIEMENS HEALTHCARE DIAGNOSTICS INC. FIELD SERVICE ENGINEER (FSE) WAS PERFORMING OPERATIONS ON THE DIMENSION XPAND INSTRUMENT AND WAS SPRAYED WITH WASTE WATER WHEN REMOVING A BLOCKAGE IN THE WASTE DRAINAGE LINE. THE FSE AND A LABORATORY OPERATOR WERE SPRAYED IN THE FACE AND EYES. THE FSE AND OPERATOR BOTH RECEIVED MEDICAL ATTENTION TO FLUSH THEIR EYES WITH SALINE AND AN ANTIBIOTIC EYE OINTMENT WAS PRESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION® CLINICAL CHEMISTRY SYSTEM CLINICAL CHEMISTRY SYSTEM JJE SIEMENS HEALTHCARE DIAGNOSTICS INC - BROOKFIELD XPAND HM

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention