Events

3T Heater-Cooler System 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 LivaNova PLC 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 날짜
    2016-11-15
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    http://www.info.gov.hk/gia/general/201611/15/P2016111500974.htm
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Press release
  • 원인
     
    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
    archives   yesterday's press releases   back to index page back to top

    related links

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

Device

3T Heater-Cooler System
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Press release: Safety alert on contamination of heater-cooler device use in cardiothoracic surgery
  • Manufacturer
    LivaNova PLC

Manufacturer

LivaNova PLC