Failure #2: The packaging was designed badly

Look at this package. Where should you open it from? For us, it was obvious: Open from the non-label side (bottom), since opening from the label side would be a pain. Instead, first-time users of the package did what we would all expect given our previous packaging experiences as consumers: Open where the label is.

Our attempt to create a faster-opening system actually delayed use of the device. No easy place to grab the seal also lost precious seconds.

We responded to this by unpacking one unit per first responder for placement in an easily-accessible pocket. Since sterility is not an issue, this is not a problem. However, we have no great ideas for how to solve this problem going forward, and will have to trial some options to see what works best.

Failure #3: We deployed an old model we knew had the potential for internal belt failure

New model tested to failure on manikin. Source: Glia. License: CC-By-SA

When we started training with the tourniquet, we quickly discovered a problem: Twisting the windlass (the stick) too many times resulted in a catastrophic failure of the tourniquet. This was especially true in lower limbs, where higher energy was required. This was largely due to a sharp edge on the windlass, which we discovered quickly.

After making corrections, we tested the new model to failure and found it withstood approximately 5 times more force before non-catastrophic failure resulting in an unstable tourniquet — more than enough for our use-cases.

I made a strategic decision, due to the large number of injuries and the low number of tourniquets for us to deploy the earlier model with the known problem. I thought — incorrectly — that they would survive a single use, which all of our laboratory testing showed that they should.

Approximately one quarter of the deployed units contained this defect. I used one of them on a patient with a partially amputed left leg, I think just below the knee. The tourniquet was applied quickly proximal to the knee while the patient was being carried on a stretcher. The stretcher bearers, paramedics and I were all running. He was not tourniqueted when I arrived. As the tourniquet was not tightly applied before I turned the windlass, I had to turn it more than is ideal. The tourniquet broke, and I used a torn up cloth for a makeshift tourniquet to salvage the situation. I recovered the pieces of the tourniquet after the patient was stabilized. As of today, we have pulled all remaining early models from our inventory.

Top: Recovered windlass of old model used on patient that failed catastrophically. Note sharp edge in belt slot. Bottom: New model. Note curved edges.

The second failed unit most likely harmed a patient and had a very real risk of killing him. This is the case I will lose sleep over.

The patient had a gunshot in the proximal left thigh that hit a vessel, likely not arterial. We arrived within about 15 seconds of the injury, and the tourniquet was placed by a trained first responder proximal to the injury. As he turned the windlass, it was as though somebody was turning off a tap, and the patient’s bleeding stopped. However, an untrained first responder wanted to turn the windlass a few more times for good measure, unbuckled the windlass from its holder, and turned it several more times until it broke.

The patient’s bleeding was controlled enough by the primary action of the tourniquet (pull and velcro) that we decided to transport rather than reapply another tourniquet. I do not know the outcome of this patient.