Class I Recall of Terumo Sarns TCM and TCM II Cooling and Heating Systems and HX2 Temperature Management Systems
The U.S. Food and Drug Administration (FDA) has announced the Class I Recall of Terumo’s Sarns TCM and TCM II Cooling and Heating Systems and HX2 Temperature Management System due to revised cleaning instructions.
In response to the FDA’s ongoing investigation of Nontuberculous Mycobacteria Infections associated with heater-cooler devices, Terumo has revised their cleaning instructions for their Sarns™ TCM, TCM II, and HX2™ heater-cooler devices to reduce the risk of infection to patients.
There is the potential for non-tuberculous mycobacteria (NTM) to grow in the water tank of the heater-cooler units. While the water in the heater-cooler unit does not encounter the patient's blood or body fluids, the contaminated water droplets from the tank may aerosolize bacteria as it escapes from the heater-cooler unit into the operating room environment. This may lead to infection or other adverse events, primarily in cardiovascular patients undergoing open-chest surgical procedures.
On March 19, 2018 Terumo sent an Urgent Medical Device Correction notice to all affected customers informing them of the updated cleaning guides. The notice asked customers to:
- Discard any current Sarns™ TCM or TCM II Cooling and Heating Systems, or HX2™ Temperature Management Systems cleaning guides.
- Review the Medical Device Correction notice and the updated cleaning guides, and ensure the appropriateRe staff is aware of the updated cleaning guides. The updated cleaning guides include:
- Clarifying the use of disinfectant wipes when wiping the surfaces of the devices
- Using a 0.22-micron filter when filling, refilling, topping off and/or rinsing the devices
- Performing fill and prime, and draining three times
- Using maintain mode for running the cooling section of the HX2 system
- Meeting the chlorine level
- Using a new 3' tubing for each cleaning process. Then replacing the tubing used between the cooler-heater and heat exchangers after the completion of each cleaning.
- Return the Customer Response Form, acknowledging receipt of this notice, to Terumo Recall Email: email@example.com or Terumo Recall Fax: 734-741-6149.
Health care providers and staff at health care facilities should also continue to follow FDA's recommendations when using heater-cooler devices to help reduce the risk of infection to patients.
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