Events

Hemodialysis Machine, Dialog + and Dialog + HDF models online (7102005, 7102072, 710200C and 710207E), registration 80136990498, risk class III, various series (SEE ANNEX). 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Laboratórios B. Braun S.A. Endereço; B. Braun Avitum AG 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
    1825
  • 날짜
    2016-02-15
  • 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
    Reinforce the need for users NOT to use the hand-held level regulator in therapy and DO NOT perform any SN / CO single puncture therapy before certifying the perfect operation of the Dialog + SW 9.xx manual level regulator.
  • 원인
    By means of investigations by the registry holder, b. braun s / a, the possibility of reversing the positioning of the tubes between the valve block of the level regulator system and the diaphragm pump was identified. this occurs during any technical intervention or maintenance measures if the functionality of this level regulator system is not properly tested as required in the service manual. this can occur during any repair or maintenance activity where it is necessary to disconnect and reconnect the tubes, which results in reversing the function of the manual level control system.
  • 조치
    Action code AC / 03/2015. Elaboration of Message Letter with Security Alert dated 04/4/2015 and delivery to each client involved //// Receipt of Receipt Confirmations of the Message Letter //// Correction in the field for the applicable cases through Correction of parts.

Device

Hemodialysis Machine, Dialog + and Dialog + HDF models online (7102005, 7102072, 710200C and 7102...

Manufacturer

Laboratórios B. Braun S.A. Endereço; B. Braun Avitum AG