Capa investigations have been conducted.The investigation regarding the cause of the fluid leak indicates the potential for certain tube fittings to fracture or break, which may lead to a leak.The root cause report has identified several contributing factors, including but not limited to the impact of material compatibility on potential leak sources and implementation of several categories of suboptimal leak mitigation measures within the instrument (for example, lack of hose clamps to keep fluidics tubing from separating from fittings).Local field service engineers will perform specific service actions, including the installation of a power connector shield, which will prevent fluid entry into the power cord connection and socket, inspection of specific instrument parts for signs of cracks and fluid leaks, and completion of the waste tub and filter upgrade, if needed.(b)(4).
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