Events

Trade name: ACCEL SYSTEM FOR COLLECTION OF BLOOD COMPONENTS Technical name: System for collection of blood components ANVISA registration number: 80554210015 Hazard class: III Affected model: ACCEL SYSTEM FOR COLLECTION OF BLOOD COMPONENTS 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Terumo BCT Tecnologia Médica Ltda.; Terumo BCT Inc. 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
    2203
  • 날짜
    2017-02-16
  • 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
    1) Distribute this notification to all Trima Accel System users within their organizations. 2) Review the supplement of the operator's manual attached to this chart with all users of the Trima Accel System, making it available for consultation whenever necessary. 3) Continue to use Trima Accel Systems as instructed in the operator's manual and supplement contained in this chart. 4) Important: Fill out the receipt form (Annex II - Receipt Confirmation Form) and send it signed to andrea.wecchi@terumobct.com as soon as possible and before 03/31/2017. Sending this completed and signed form is essential to ensure that the information in this security alert has been received by all users.
  • 원인
    Terumo bct issues this safety alert in order to inform users of the trima accel system that there is the possibility, however rare, of the iv pole column to download quickly when the release button is pressed. if a user does not hold the iv pole when lowering it, it may fall with intensity that would be sufficient in extreme cases to cause injury to the user if he, for example, keeps his hands on the path where the iv pole column goes down . terumo bct received only one report of an injury suffered by a user and other reports that the iv pole column is lowered quickly but without causing any damage. this possible safety risk exists with all trima accel system equipment in the following situation: if the user does not hold the iv pole column by pressing the release button, the iv pole column could descend freely. the force that the iv pole pole in free fall could cause injury if the hands or any other part of the user's body is in the downward path of the iv pole pole.
  • 조치
    Field Action Code FA 30 triggered under the responsibility of the company Terumo BCT Tecnologia Médica LTDA. Company will update, correct or supplement the instructions for use.

Device

Trade name: ACCEL SYSTEM FOR COLLECTION OF BLOOD COMPONENTS Technical name: System for collection...

Manufacturer

Terumo BCT Tecnologia Médica Ltda.; Terumo BCT Inc.