Mycobacterium chimaera Analysis

Stockert 3T Heater Cooler Systems

      The FDA has updated the safety communication for the contamination potential of Mycobacterium chimeara associated with LivaNova PLC Stockert 3T Heater-Cooler Systems. The 3T system helps to control a patient’s body temperature during open-heart surgery. While the water in the system does not come into contact with the patient during normal usage, there is a potential risk for the Mycobacterium to become aerosolized through the systems exhaust vent. While generally not harmful to healthy people, the bacteria poses a serious risk for patients with weakened immune systems.

CDC’s Mycobacterium chimaera infection outbreak study

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For Mycobacterium chimaera testing information, contact Assured Bio today. Fill out the form or call toll-free at 1-866-547-1727

Sample Collection

      Using our proprietary Passive mTrap™ technology, we provide an easy method for collecting samples from the heater-cooler system. The Passive mTrap™ attaches to the unit near the exhaust vent and will passively test the air passing through. This provides an easy setup with no additional pumps or power cords. It is recommended that the minimum sampling period is 10 hours of run time. However, since the Passive mTrap™ cannot be overloaded, longer periods are encouraged. The cassette may be left in place for a week to 10 days of run time. A link to the sample protocol below goes through the details of collection. 

passive-mtrap

 

 

Sample Collection Protocol

 

Chain of Custody

 

American Industrial Hygiene Association Accredited (AIHA Lab ID# 183867)