A transportation simulation test revealed the problem, according to an August 27, 2019, letter to customers. Patients who are exposed to non-sterile medical devices while undergoing extracorporeal circulation may develop an infection and systemic inflammatory response syndrome (SIRS), the company said.
Rastatt, Germany-based Maquet said it had not received any complaints of damage to the product’s sterile barrier or about serious injuries or death attributed to such damage. The Quart arterial filter is designed to eliminate air bubbles and particles in the blood during perfusion.
You can read more about the pitfalls of sterile medical device packaging here.