Due to our inhouse development of a heart-lung machine (HLM), em-tec has accumulated an extensive know-how in the field of all components of mechanical circulatory support systems. A customer was looking for a manufacturer of external drive components (centrifugal pump) that starts at the single-use tubing system and ensures the blood flow. With the help of several interfaces, the pump system can be attached to the control unit of the heart-lung machine.
On the basis of detailed manufacturing instructions, em-tec was commissioned for the manufacturing, testing and certification of this HLM component. At this stage, the challenge this poses is to provide an unchanged functionality and quality of the product component based on the product development that, at this stage, took place more than 20 years ago. Since the further development of the existing HLM is not intended any more, the functionality of the RotaFlow Drive RFD pump with the intial system as well as the awarded certification need to be ensured. In addition, there are complexe adjustment and calibration processes that need to be carried out. Partial components of the centrifugal pump that are no longer available need to be substituted with equivalent parts without questioning the approval of the complete system or its functionality. Furthermore, the full traceability of all used product components must be guaranteed so that, in case of errors, all affected devices can be quickly and reliably identified.
With the RotaFlow Drive RFD, the customer has been receiving a partial product for a heart-lung machine for more than 20 years. The product fits seamlessly into the complete system and is, even with components that are, from today's view, no longer up-to-date utterly reliable. Currently, we manufacture, adjust and, following extensive documentation, deliver about 300 RotaFlow Drive RFD systems per year. Due to the continuous quality assurance in close coordination with our quality management and the development department, the adherence to relevant standards is guaranteed at all times.
External centrifugal pump for a heart-lung machine
> 20 years
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