Events

Safety Alert for 3T Heater-Cooler System

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by LivaNova PLC.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2016-11-15
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    http://www.info.gov.hk/gia/general/201611/15/P2016111500974.htm
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Press release
  • Reason
     
    safety alert on contamination of heater-cooler device use in cardiothoracic surgery
    ***********************************************************************************
         the department of health (dh) today (november 15) drew the public's attention to safety alerts issued by food and drug administration (fda) of the united states on an association between mycobacterium chimaera (m. chimaera) infections and heater-cooler device use in cardiothoracic surgery.

         the dh made this appeal following the hospital authority’s notification regarding two patients found to be contracted with m. chimaera infection after receiving open-chest cardiac surgery.

         according to the fda, a possible association was found between the use of stöckert 3t heater-cooler system (3t) and m. chimaera infection, primarily in patients undergoing cardiothoracic surgical procedures.  the concerned system is manufactured by livanova plc (formerly sorin group deutschland gmbh). 

         heater-cooler devices are commonly used during cardiothoracic surgeries, as well as other medical and surgical procedures, to warm or cool a patient in order to optimize medical care and improve patient outcomes. heater-cooler devices have water tanks that provide temperature-controlled water to external heat exchangers or warming/cooling blankets through closed circuits. although the water in the circuits does not come into direct contact with the patient, there is the potential for contaminated water to enter other parts of the device and aerosolise, transmitting bacteria through the air and through the device's exhaust vent into the environment and to the patient.

         the fda has issued recommendations and guidance notes to healthcare providers, hospitals and health departments to mitigate risks of patient infection.

         in response to fda’s safety alerts, the dh has already contacted the local supplier for follow-up actions. according to the local supplier, the affected products were distributed to six public and private hospitals in hong kong. all of them have been notified of the latest alerts and recommendations issued by the fda.  they are also advised to follow the manufacturer’s updated operation instructions. the dh will continue to liaise with the local supplier on necessary follow-up actions.  moreover, the dh will also inform public and private hospitals and relevant medical associations about the fda’s alerts and recommendations.

         m. chimaera infections may present with symptoms months after initial exposure. patients who have undergone open chest cardiothoracic surgery and experience suspicious symptoms of m. chimaera infection, such as night sweating, muscle aches, unexplained weight loss, fatigue or unexplained fever, are advised to seek medical evaluation by their cardiothoracic surgeons.
     
     
    ends/tuesday, november 15, 2016
    issued at hkt 22:24
    nnnn
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    related links

    hospital authority announces infection risks of using heater-cooler device in cardiothoracic surgeries
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Device

3T Heater-Cooler System
  • Model / Serial
  • Product Description
    Press release: Safety alert on contamination of heater-cooler device use in cardiothoracic surgery
  • Manufacturer
    LivaNova PLC

Manufacturer

LivaNova PLC