Events

Bulk Loader (BLM), integral module of the Cobas p 512/612; Registration 10287411043; Hazard Class I, Serial Number: 7501721; 7501821; 7501921; 7502021. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH 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
    1706
  • 날짜
    2015-10-01
  • 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
    Unexpected spills, aerosols, or blood droplets may occur when equipment is improperly unplugged. There are no known cases of serious adverse events. #### Update of the field action: UPDATED ON 10/27/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.
  • 원인
    Inadvertent opening of the sample tube during the transport process with risk of user contamination and sample loss. the root cause of the problem is related to the design of the repellent plate bevel, which is the component of the tube inlet basin.
  • 조치
    The company will make a field correction of the equipment in which it will develop a kit of modification for the equipment. Until the corrective measure with the modification kit is implemented, if the problem occurs, the equipment must be cleaned according to the operating manual.

Device

Bulk Loader (BLM), integral module of the Cobas p 512/612; Registration 10287411043; Hazard Class...

Manufacturer

Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH