According to the Food & Drug Administration’s report, five people have died since 2016 after being treated with weight loss balloon devices. The science behind this technology is that the balloon takes up space in the stomach after being filled with solution and this leaves less room in the stomach for food. The balloon is left in the patient’s stomach for six months while the patient learns to eat differently.

The five deaths occurred within a month of balloon placement.  We know that four of the deaths involved a balloon from the same manufacturer. However, nothing has been found linking the deaths to the medical device. In the TapRooT® System, an investigator would examine an incident like this by first creating a sequence of events. Once the sequence of events is completed,  more information would be collected.  For example:

Did the patient understand the risks?

Was the patient closely monitored by the healthcare team for possible deteriorations?

Did the patient understand which symptoms required medical assistance?

These are just a few of the types of questions that should be answered to help determine all the Causal Factors. There could be multiple things that went wrong. TapRooT® doesn’t stop at Causal Factors. Each Causal Factor is taken through the TapRooT® Root Cause Tree to find the Root Causes. Just like there may be (and probably is) more than one Causal Factor, there is probably more than one Root Cause that needs to be fixed to prevent this from happening again.

Mark Paradies recently posted an article that may be helpful in a situation like this, “Root Cause Analysis for the FDA.”

It takes some deep diving to understand all of the lessons learned here. Learn more about how to prevent unnecessary deaths like this in one of our upcoming 5-Day TapRooT® Advanced Root Cause Analysis Team Leader Trainings:

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