Datamiser Case Study | Fresenius Medical Care

Location: Waltham, MA

Customer Since: February, 2012

Key Benefits
  • Major improvement in quality standards
  • Improved reporting capabilities
  • Better insight into production defects


Fresenius Medical Care operates more than 2,100 dialysis facilities in North America and a network of vascular access centers, laboratory, pharmacy and affiliated hospitals and nephrology practices. Fresenius Medical Care provides renal services to hundreds of thousands of people throughout the United States, Mexico and Canada. They are also the continent’s top producer of dialysis equipment, dialyzers and related disposable products and a major supplier of renal pharmaceuticals.

Fresenius Medical Care North America is a division of Fresenius Medical Care (NYSE: FMS), the world’s largest integrated provider of products and services for individuals undergoing dialysis because of chronic kidney failure, a condition that affects more than 2.1 million individuals worldwide.

The Problem and Solution

Fresenius needed a solution for quality improvement and auditing purposes. The federal government (FDA) mandates quality levels, proper documentation, repeatability, and traceability of drug mixtures and recipes used in the manufacturing process. This required precision tracking and reliable data logging. Savance provided the answer with their Datamiser solution. Each time a mixture was made and a bag of the dialysis chemicals were mixed and weighed, our system would capture and log the critical details. Any time a bag was automatically rejected or manually rejected, our system would capture the reason along with audit information to show history. This allowed Fresenius to stay in compliance with the government and better understand their top reject reasons and out of spec details in real-time. This enabled them to make decisions faster and improve process immediately.

In addition, since our system logs data for an extended period of time, data can be analyzed over longer periods to help identify trends that may not be immediately obvious. For example, Fresenius learned that many punctures were occurring due to an issue with the packaging machine that was creating enough rejects in one month to pay for the modifications required to address the project.

Reporting Examples