Events

BLOOD LINE FOR HEMODIALYSIS MACHINES. Bloodlines - Medisystems Corp., product code: D3-9694 / 9793 or K3-9694 / 9793, Baxter product code 5M9694. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Baxter Healthcare 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
  • 사례 ID
    674
  • 날짜
    2002-09-23
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • 데이터 추가 비고
    BRAZIL - 24.09.2002 (12:17 h) - ANVISA is conducting the survey if the product is registered nationwide. BRAZIL - 06.11.2002 - To date, Meridian products (dialysis machine) and blood, arterial and venous lines of Medisystems are not registered in Brazil and therefore are not marketed in this country. In this way, the recall announced by the FDA on 12.09.02 did not reach Brazil. (Baxter)
  • 원인
    Some blood lines used with baxter meridian dialysis machines may possibly be linked to five patient deaths and two injuries. the incidents occurred at the nephrology clinic, inc., mishawaka, and ind., and physicians dialysis, inc., grand rapids, mich. baxter's preliminary investigation found that in the two hemodialysis centers where the incidents occurred, the following may have been used: blood lines - medisystems corp., product code: d3-9694 / 9793 or k3-9694 / 9793, code of baxter's 5m9694 product. hemodialysis machine - meridian medisystems alternative blood lines are available.
  • 조치
    The cause of the deaths has not yet been definitively determined, Baxter on September 6 notified the hemodialysis centers that they are exploring the possibility that hemodialysis treatments in patients may have used the same model of dialysis machine and line array blood. Baxter advised customers to immediately discontinue use of certain Medisystem bloodline models in conjunction with Meridian dialysis machines and request that they use other Medisystems bloodlines.

Device

BLOOD LINE FOR HEMODIALYSIS MACHINES. Bloodlines - Medisystems Corp., product code: D3-9694 / 979...

Manufacturer

Baxter Healthcare Corporation
  • Source
    ANVSANVISA