Events

HeartMate 3 Left Ventricular Assist System 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Abbott 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
    2018-04-12
  • 사례 출판 날짜
    2018-04-12
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180412a.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: heartmate 3 left ventricular assist system medical device manufacturer, abbott, has issued a medical device safety alert concerning its heartmate 3 (hm3) left ventricular assist system [catalog number: 106524int – hm3 lvas kit]. the manufacturer has received reports of outflow graft twist occlusions in the heartmate 3 left ventricular assist system. as a result, patients whose devices experience these outflow graft occlusions will experience a persistent low flow alarm. according to the manufacturer, there are 32 total reports associated with outflow graft twisting in the hm3 device, an occurrence of 0.72 percent based on 4,467 implants worldwide outflow graft twists can result in serious adverse events such as hemodynamic compromise, thrombus, and death. postoperative twisting and occlusion of the hm3 outflow graft may result in the need for surgical intervention following the original implant procedure. the affected users are advised to take the following actions: during implant, when attaching the outflow graft to the pump cover, a clicking sound will be heard as the screw ring is tightened. continue turning the screw ring clockwise until it comes to a complete stop and stops clicking for a firm hand tightened connection. if a low flow alarm persists at any time following implant, and other potential causes such as hypertension, low preload, right-heart failure and inflow occlusion have been considered for cause, a computed tomography angiography should be taken to identify the possibility of an outflow graft twist occlusion. in the event surgical repair of the outflow graft is needed due to a twist occlusion, the outflow graft bend relief should be reattached in its original state or repaired to prevent further kinking or occlusion of the graft. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 12 april 2018.

Device

HeartMate 3 Left Ventricular Assist System
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: "HeartMate 3 Left Ventricular Assist System"
  • Manufacturer
    Abbott

Manufacturer

Abbott
  • 제조사 모회사 (2017)
    Abbott Laboratories
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    DH