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Heater Cooler 3T/ Hemotherm

The Heater-Cooler System Hemotherm 3T device is designed to regulate the temperature of the patient’s blood during cardiopulmonary bypass procedures, where the patient’s heart and lungs are temporarily stopped. The Heater-Cooler System Hemotherm 3T consists of two separate units: a heater unit and a cooler unit, which are connected to the patient via tubes.

The heater unit warms the blood before it is returned to the patient’s body, while the cooler unit cools the blood before it is circulated through the bypass circuit. This helps maintain the patient’s body temperature and prevent hypothermia or hyperthermia, which can be harmful during surgery.

However, in 2015, the FDA issued a safety warning regarding the potential for contamination of the device’s water reservoir, which could lead to the transmission of dangerous bacteria during surgery. As a result, LivaNova issued a recall of the affected devices and implemented new cleaning protocols to address the issue. It’s important to note that when used properly, the Heater-Cooler System Hemotherm 3T can be a valuable tool in ensuring patient safety during cardiac surgery.

SKU: ATM MEDICALS FZC Refurbished Heater Cooler 3T/ Hemotherm Categories: , , Tags: ,

Hemotherm 3T devices, Although the bacteria did not directly enter the patient’s blood, it was aerosolized and could potentially be transmitted through the air during surgery. The risk was primarily associated with immunocompromised patients, as the bacteria could cause a severe infection known as non-tuberculous mycobacterium (NTM) infection.

In response to the FDA warning and to ensure patient safety, LivaNova, the manufacturer of the device, initiated a voluntary recall of the affected units. Additionally, they implemented enhanced cleaning and disinfection protocols for the devices to minimize the risk of bacterial transmission. It is crucial for healthcare facilities to adhere to these cleaning protocols and monitor the water quality in the device to mitigate the potential for contamination.

It’s important to note that when the Heater-Cooler System Hemotherm 3T device is used correctly, following the updated cleaning procedures and guidelines, it can still provide valuable temperature control during cardiac surgeries while maintaining patient safety. Healthcare providers are advised to stay informed about any updates or recommendations from regulatory authorities and the device manufacturer to ensure the safe and effective use of the device.



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