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Recommendations for the Use of Any Heater Cooler Device ... | 合法醫療器材資訊網

Recommendations for the Use of Any Heater Cooler Device ...

2020年9月30日—RecommendationsspecifictotheuseoftheLivaNovaPLCHeater-CoolerSystem3T;Summaryofresources.RecommendationsfortheUseof ...

 Recommendations for the Use of Any Heater Cooler Device ...

There is the potential for microorganisms (including NTM) to grow in the fluid tanks of any heater-cooler device. Contaminated water from a water-based heater-cooler device has the potential to aerosolize into the operating room during surgery. This may lead to infection, primarily in cardiovascular patients undergoing open-chest surgical procedures.

In appropriately selected patients, the benefits of temperature control during open chest cardiothoracic procedures generally outweigh the risk of infection transmission associated with the use of these devices.

On this page: Recommendations for the Use of Water-Based Heater Cooler Devices

The FDA has the following recommendations to help reduce the risk of infection to patients when using a water-based heater-cooler device. The recommendations include:

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3T Heater | 合法醫療器材資訊網
The LivaNova 3T Heater-Cooler System provides 3 circuits for fast and efficient heating and cooling to meet your patient and cardioplegia temperature needs. Read More
UPDATE | 合法醫療器材資訊網
2020年2月25日 — ... of cardiac surgery infection when using the LivaNova Heater-Cooler ... the LivaNova Heater-Cooler System 3T: FDA Safety Communication. Read More
Recommendations for the Use of Any Heater Cooler Device ... | 合法醫療器材資訊網
2020年9月30日 — Recommendations specific to the use of the LivaNova PLC Heater-Cooler System 3T; Summary of resources. Recommendations for the Use of ... Read More
LivaNova Receives FDA Clearance for 3T Heater | 合法醫療器材資訊網
2020年2月25日 — LivaNova Receives FDA Clearance for 3T Heater-Cooler Device Modification · since October 2018 . · customers its 3T device loaner program, as ... Read More
LivaNova Sorin Stockert 3T | 合法醫療器材資訊網
The LivaNova Sorin Stockert 3T is a heater-cooler that is used during cardiopulmonary bypass. The System is used to help regulate the patient's blood during ... Read More
Heater-Cooler Devices | 合法醫療器材資訊網
The most commonly used model of heater-coolers, LivaNova's Stockert 3T, has been linked to the spread of bacteria called nontuberculous mycobacteria (NTM). Read More
LivaNova to settle majority of U.S. 3T Heater | 合法醫療器材資訊網
2019年3月29日 — LivaNova (NSDQ:LIVN) said that it inked a deal to settle approximately 75% of litigations it faces in the U.S. related to its 3T Heater-Cooler ... Read More
LivaNova 3T Heater-Cooler Deep | 合法醫療器材資訊網
A1: The deep-cleaning service is a free of charge special service implemented by LivaNova that allows facilities to return heater-cooler units for a full cleaning, ... Read More
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