Root Cause Analysis Information

Heparin Contamination – 19 Lives Lost

by Agriffith on April 6, 2008

Download PDFHeparin, which is widely used as an anticoagulant (blood thinner) has been in the news lately and the news is scary.  19 people have died, and 785 have experienced adverse reactions due to contaminated heparin.  The heparin in question has been found to contain up to 50% oversulfated chondroitin sulfate, which mimics heparin so closely it can not be distinguished in basic tests but provides no anticoagulant activity.  The adverse effects are caused by severe allergic reactions, including low blood pressure which can occasionally lead to fatal stroke.

Whether or not the chondroitin sulfate is to blame for the allergic reactions, it also has the potential to cause serious harm by negatively affecting the blood thinning properties of Heparin.  People who take heparin because they require its anticoagulant properties may have serious difficulties with a dose that is only 50% effective.  Because of these concerns, the Heparin in question is taken off the market.  But serious consumer concerns remain about the system that allowed the contamination to happen in the first place.  Due to the potential for fatal side effects, lots of heparin (the total amount is unclear) have been recalled from 6 countries (at last count).

A thorough root cause analysis built as a Cause Map can capture all of the causes in a simple, intuitive format that fits on one page.  Click on the pdf document for a more detailed analysis.

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