LivaNova—Perfusion Tubing Systems Containing Stopcocks and Stopcock Manifolds: May Leak or Be Occluded
November 21, 2018 | Strategic Insights for Health System
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In a November 9, 2018, Medical Device Correction letter submitted by ECRI Institute member hospitals, LivaNova states that the above 4-way stopcocks and stopcock manifolds assembled in certain Perfusion Tubing Systems, indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours, may leak or be occluded. The firm has received no reports of injuries associated with this problem. LivaNova also states that the probability of these defects causing patient harm is low; however, the potential for hypovolemia, bacteriemia leading to sepsis,...