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Following reports of nontuberculous mycobacterium (NTM) infections linked to Sorin 3T cardiac surgery heater-coolers in recent years, federal health officials have announced a recall for a different heating and cooling system, to provide revised cleaning instructions.
On Monday, the FDA announced a recall for Sarns TCM and TCM II Cooling and Heating Systems, as well as HX2 Temperature Management Systems, which are all manufactured by Terumo and used for regulating patient body temperature during surgery. However, it is unclear if any NTM infections have been linked to the devices.
Similar to the problems with Sorin 3T Heater-Coolers, the recall indicates that Terumo found there is a potential for nontuberculous mycobacterium (NTM) to grow in the water tanks of the recalled units, which could then be transferred to patients, resulting in infections and other adverse events, particularly for patients undergoing cardiovascular surgery.
As a result, the manufacturer has revised the cleaning instructions for the Sarns TCM, TCM II and HX2 heater-cooler devices. The company sent a letter to customers in March announcing the new cleaning instructions, and on May 7 the FDA declared that the action constitutes a recall.
The recall affects the Sarns TCM and TCM II Cooling and Heating Systems, and the HX2 Temperature Management Systems. The affected TCM units have a catalog number of 15747; the TCM II units have catalog numbers of 4415, 4416, 164925, 164930, 16435, and 164940; and the HX2 has a catalog number of 809810. The devices were manufactured between May 2, 1985 and March 20, 2013, and distributed between May 2, 1985 and June 10, 2015. About 450 devices are affected by the recall.
The company is asking customers to discard any previous cleaning guides and review the Medical Device Correction notice and the updated cleaning guides.
3T Heater-Cooler Infection Lawsuits
The recall comes amid a growing number of NTM infections linked to heater cooler units.
Concerns about the link between Sorin 3T Heater-Coolers and NTM infections emerged in 2015, after the FDA warned about a large number of adverse event reports received involving infections or bacterial contamination involving the surgical heater-cooler systems.
Sorin 3T Heater-Coolers are commonly used during open heart surgery to regulate blood temperature during bypass surgery, valve replacement surgery and other cardiac procedures. However, it was discovered that certain devices manufactured prior to September 2014 may be contaminated with a slow growing bacteria, which can cause life-threatening infections to surface months or even years after exposure.
Contaminated vapors may be released by the devices, posing a serious risk for individuals with a compromised immune system and open chest cavity during the surgery, leading to multiple reports of Mycobacterium chimaera or Mycobacterium abscessus infections.
In June 2016, a panel of experts were convened to evaluated the problems, indicating that at least 34 reports involving bacterial infections following heart surgery involving heater-cooler systems had been received between January 2010 and August 2015.
In late 2016, the federal regulators issued a safety communication warning about the infection problems with 3T Heater-Coolers, indicating that water tanks used by the devices can become contaminated and spread contaminants to other parts of the system, where they can be released into the air of the operating room.
Dozens of 3T Heater Cooler lawsuits have been filed against the manufacturer of the device, on behalf of individuals diagnosed with NTM infections following heart surgery where a contaminated heater-cooler may have been used.
Given similar questions of fact and law raised in complaints pending in federal courts nationwide, the U.S. Judicial Panel on Multidistrict Litigation recently established consolidated pretrial proceedings for the cases, centralizing the claims before U.S. District Judge John E. Jones III in the Middle District of Pennsylvania to reduce duplicative discovery into common issues, avoid conflicting pretrial rulings and serve the convenience of the parties, witnesses and the courts.