Events

Advanced Perfusion System 1 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Terumo Cardiovascular Systems Corporation 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
    2012-08-17
  • 사례 출판 날짜
    2012-08-17
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120817b.html
  • 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
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: terumo advanced perfusion system 1 medical device manufacturer, terumo cardiovascular systems corporation, has issued a medical device safety alert concerning terumo advanced perfusion system 1. terumo cardiovascular systems (terumo cvs) has received ten reports of malfunctions between 2006 and 2010 involving the loss of data transfer capabilities using the following modules for the terumo advanced perfusion system 1: serial interface module rs-232 serial interface module rs-485 interface module for cdi system 100/101 interface module for cdi system 500 some reports stated that the odor of smoke was associated with the failures. according to the manufacturer, the malfunctions occurred during set-up, during cardiopulmonary bypass, and during routine testing of the module. terumo cvs' investigation has determined that the malfunctions are caused by a circuit board that failed. based on the information provided by the local supplier, the affected products have not been distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 17 august 2012.

Device

Advanced Perfusion System 1

Manufacturer

Terumo Cardiovascular Systems Corporation